July 26, 2008FDA Approves Diaphragm-Pacing Device FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Wrinkle Relief: Injectable Cosmetic Fillers Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions New Medical Products: New Skin Graft Adhesive Approved New Medical Products: New Skin Graft Adhesive Approved
FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... FDA Approves First Generic Risperidone to Treat Psychiatric Conditions The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. FDA narrows its warning to avoid jalapenos just from Mexico, not the - Los Angeles Times FDA narrows its warning to avoid jalapenos just from Mexico, not the - Los Angeles Times
WASHINGTON (AP) _ Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos Source: www.latimes.com FDA: Avoid jalapenos from Mexico, not US - AG Weekly WASHINGTON - Only jalapeno peppers grown in Mexico seem to be implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos Source: www.agweekly.com Maha Govt to inspect Subhiksha godowns over hygiene complaints - Hindustan Times The Maharashtra government on Saturday announced to recheck godowns of 'Subhiksha' store chain following complaints of violation of hygiene norms. Deputy chairman of the Legislative Council Vasant Davkhare asked the government to recheck the godowns Source: www.hindustantimes.com FDA: Avoid Jalapenos From Mex., Not U.S. - The Ledger WASHINGTON | Only jalapeno peppers grown in Mexico seem to be implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos Source: www.theledger.com FDA: Watch out for Mexican jalapenos - Detroit News WASHINGTON -- Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos and Source: www.detnews.com FDA: Avoid jalapenos from Mexico, not US - BusinessWeek FDA: Avoid jalapenos from Mexico, not US - BusinessWeek
Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos and the serrano Source: www.businessweek.com AP: Food Industry Bitten by Its Lobbying Success - ABC News In this July 17, 2007 file photo, William Hubbard, former Associate Commissioner of the Food and Drug Administration, testifies on Capitol Hill in Washington. Source: www.abcnews.go.com Genetic test urged before trying AIDS drug - MSNBC WASHINGTON - AIDS patients should have a genetic test before treatment with GlaxoSmithKline Plc's drug Ziagen to see whether they face a higher risk of a potentially fatal reaction, U.S. regulators said on Thursday. For patients who test positive for Source: www.msnbc.msn.com Drug Test a Success for Amgen - New York Times Amgen ’s experimental bone drug, widely considered to be crucial to the company’s future, has succeeded in its most important clinical trial, sending the company’s shares up sharply. Amgen said the drug reduced the risk of both spine and hip Source: www.nytimes.com Profits up, drug makers pledge to cut more jobs - International Herald Tribune Bristol-Myers Squibb and Eli Lilly both reported increases in second-quarter profit and revenue on Thursday and said they planned to cut more jobs. Helped by the weak dollar, both had faster growth in sales overseas but also posted improvements in Source: www.iht.com Grocery chain Kroger removes all jalapenos as precaution - Newsday CINCINNATI (AP) _ The nation's largest traditional grocery chain has removed jalapeno peppers from its stores as a precaution. Kroger Co. spokeswoman Meghan Glynn said Thursday it decided to halt jalapeno sales after the U.S. Food and Drug Source: www.newsday.com Time to Regulate Big Tobacco - New York Times The House of Representatives is poised to vote next week on a pioneering bill that would give the Food and Drug Administration its first real power to regulate tobacco products, much as it now regulates food, drugs and medical devices. This is a Source: www.nytimes.com FDA: Avoid Jalapenos From Mex., Not U.S. - The Ledger WASHINGTON | Only jalapeno peppers grown in Mexico seem to be implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos Source: www.theledger.com Rize 2 The Occasion Capsules and Rose 4 Her Capsules Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Certain lots of both products were recalled because they contained an undeclared ingredient. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. FDA Approves New Genetic Test for Patients with Breast Cancer FDA Approves New Genetic Test for Patients with Breast Cancer
The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Herceptin 440 mg Vials and BWFI Diluent Herceptin 440 mg Vials and BWFI Diluent
Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Recall of Nestle Pure Life Purified Water (June 24) This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). FDA seizes drugs from firm - Miami Herald FDA seizes drugs from firm - Miami Herald
The Food and Drug Administration warned people it could be dangerous to take the tablets, which are sold under the brand name Xiadafil VIP, made by SEI Pharmaceuticals. Source: www.miamiherald.com Mexico peppers in FDA hot seat - Chicago Tribune WASHINGTON — Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos and Source: www.chicagotribune.com FDA narrows its warning to avoid jalapenos just from Mexico, not the - Los Angeles Times WASHINGTON (AP) _ Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos Source: www.latimes.com Avoid Mexican jalapeños, FDA says in clearing U.S. crop - Seattle Times WASHINGTON — Only jalapeño peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government said Friday in clearing the U.S. crop. The Food and Drug Administration (FDA) urged consumers to avoid raw Mexican jalapeños Source: seattletimes.nwsource.com California Becomes First State to Ban Trans Fats From Restaurant Food - FOX News SACRAMENTO, Calif. — California on Friday became the first state to ban trans fats from restaurant food, following several cities and major fast-food chains in erasing the notorious artery-clogger from menus. Gov. Arnold Schwarzenegger signed Source: www.foxnews.com Feds finally track down source of salmonella - jalapeño peppers from - Dallas Morning News WASHINGTON – In the long search for the origins of the salmonella outbreak, the Food and Drug Administration has finally settled on a single product (jalapeño peppers) and a country (Mexico). But the four-month search hasn't been easy. Although a Source: www.dallasnews.com Mich. rep wants food records improved - Detroit News WASHINGTON -- The food industry must drop any remaining opposition to electronic record-keeping and back an effective system for tracing contaminated food to its source, a lawmaker investigating food safety said Friday. "It is my hope that the food Source: www.detnews.com Roche arthritis drug works: FDA staff - Reuters WASHINGTON (Reuters) - Roche Holding AG's drug Actemra, known generically as tocilizumab, appears to be effective for treating rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday. Food and Drug Administration staff said Source: www.reuters.com FDA seizes drugs from firm - Miami Herald FDA seizes drugs from firm - Miami Herald
The Food and Drug Administration warned people it could be dangerous to take the tablets, which are sold under the brand name Xiadafil VIP, made by SEI Pharmaceuticals. Source: www.miamiherald.com Safety of cloned animal products uncertain - EU agency - Reuters India BRUSSELS (Reuters) - The European Union's top food safety agency said on Thursday cloned animal products may not be safe and further study was needed. "It is clear there are significant animal health and welfare issues for surrogate mothers and Source: in.reuters.com FDA: Avoid jalapenos from Mexico, not US - Boston Globe WASHINGTON— Only jalapeno peppers grown in Mexico seem to be implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican Source: www.boston.com Feds finally track down source of salmonella - jalapeño peppers from - Dallas Morning News WASHINGTON – In the long search for the origins of the salmonella outbreak, the Food and Drug Administration has finally settled on a single product (jalapeño peppers) and a country (Mexico). But the four-month search hasn't been easy. Although a Source: www.dallasnews.com FDA: Avoid jalapenos from Mexico, not US - Guardian Unlimited WASHINGTON (AP) - Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos Source: www.guardian.co.uk FDA seizes drugs from firm - Miami Herald FDA seizes drugs from firm - Miami Herald
Federal agents have seized $74,000 worth of tablets from a Miami company that claimed it was making ''an all-natural sexual stimulant'' when in fact it was selling unapproved pills that contained a chemical similar to what's found in Viagra. The Food Source: www.miamiherald.com Arnie terminates trans fats - News.com.au CALIFORNIA Governor Arnold Schwarzenegger signed a new law today that will outlaw artificial trans fats in restaurants from 2010. Echoing a similar law in New York – which put a blanket ban on the sale of all foods containing trans fats earlier Source: www.news.com.au How food industry lobbying slowed salmonella search - San Francisco Gate The food industry must drop any remaining opposition to electronic record-keeping and back an effective system for tracing contaminated food to its source, a lawmaker investigating food safety said Friday. "It is my hope that the food industry will Source: www.sfgate.com Mexican peppers caused illnesses - San Francisco Gate Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos and the serrano Source: www.sfgate.com Jalapeños from the U.S. are safe to eat, FDA says - Fort Worth Star-Telegram WASHINGTON — Only jalapeño peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapeño and Source: www.star-telegram.com FDA says avoid jalapenos from Mexico, not the U.S. - Beacon News WASHINGTON -- Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos and Source: www.suburbanchicagonews.com Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19)
The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. July 25, 2008U.S. narrows salmonella warning to Mexican jalapenos - Reuters U.S. narrows salmonella warning to Mexican jalapenos - Reuters
WASHINGTON (Reuters) - U.S. health officials urged consumers on Friday to avoid only raw jalapeno peppers from Mexico, narrowing an earlier warning against eating any fresh jalapenos amid an outbreak of salmonella illness. The Food and Drug Source: www.reuters.com Safety of cloned animal products uncertain - EU agency - Reuters India BRUSSELS (Reuters) - The European Union's top food safety agency said on Thursday cloned animal products may not be safe and further study was needed. "It is clear there are significant animal health and welfare issues for surrogate mothers and Source: in.reuters.com Food industry lobbying - MSNBC WASHINGTON - One of the worst outbreaks of foodborne illness in the U.S. is teaching the food industry the truth of the adage, "Be careful what you wish for because you might get it." The industry pressured the Bush administration years ago to limit Source: www.msnbc.msn.com U.S. struggles to trace food in crises - MSNBC WASHINGTON - When there's an urgent need to trace fruits and vegetables in a crisis like the salmonella outbreak, a lot of the pieces for a rapid-response system are in place. But nobody has quite figured out how to put them together to operate Source: www.msnbc.msn.com Eisai's Proposed Sedative Gets 'Not Approvable' Letter From FDA - Wall Street Journal Eisai Co. received a not approvable letter from the Food and Drug Administration for its proposed sedative, but the company said it would work with regulators to gain approval. A not approvable letter from the drug-regulatory agency describes Source: online.wsj.com FDA: Avoid jalapenos from Mexico, not US - Miami Herald WASHINGTON Only jalapeno peppers grown in Mexico seem to be implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos Source: www.miamiherald.com Eisai pre-surgery sedative rejected by FDA - MSN MoneyCentral Eisai pre-surgery sedative rejected by FDA - MSN MoneyCentral
NEW YORK (AP) - Japanese pharmaceutical company Eisai Co. said Friday the Food and Drug Administration rejected the company's pre-surgery sedative candidate, months after an advisory panel recommended its approval. The drug is meant as a sedative for Source: news.moneycentral.msn.com FDA says U.S. jalapenos safe to eat - News 14 RALEIGH – The Food and Drug Administration said Friday that jalapeno peppers from the U.S. are safe to eat. The FDA had issued a warning earlier this month that jalapenos could be the source of the Salmonella outbreak that has infected 1,200 people Source: news14.com AP: Food Industry Bitten By Its Lobbying Success - CBS News (AP) One of the worst outbreaks of foodborne illness in the U.S. is teaching the food industry the truth of the adage, "Be careful what you wish for because you might get it." The industry pressured the Bush administration years ago to limit the Source: www.cbsnews.com FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. Warning for Regranex—Cream for Leg and Foot Ulcers Warning for Regranex—Cream for Leg and Foot Ulcers
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Publix Issues Recall for No Sugar Added Cherry Pie (July 24) Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel: Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA 1/2 Cherry Pie, UPC: 03000-00225; and Publix NSA 1/4 Cherry Pie, UPC: 41415-66990. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Food industry bitten by its lobbying success - Forbes Food industry bitten by its lobbying success - Forbes
The food industry must drop any remaining opposition to electronic record-keeping and back an effective system for tracing contaminated food to its source, a lawmaker investigating food safety said Friday. "It is my hope that the food industry will Source: www.forbes.com U.S. struggles to trace food in crises - MSNBC WASHINGTON - When there's an urgent need to trace fruits and vegetables in a crisis like the salmonella outbreak, a lot of the pieces for a rapid-response system are in place. But nobody has quite figured out how to put them together to operate Source: www.msnbc.msn.com Roche arthritis drug works: FDA staff - Reuters WASHINGTON (Reuters) - Roche Holding AG's drug Actemra, known generically as tocilizumab, appears to be effective for treating rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday. Food and Drug Administration staff said Source: www.reuters.com U.S. narrows salmonella warning to Mexican jalapenos - Reuters WASHINGTON (Reuters) - U.S. health officials urged consumers on Friday to avoid only raw jalapeno peppers from Mexico, narrowing an earlier warning against eating any fresh jalapenos amid an outbreak of salmonella illness. The Food and Drug Source: www.reuters.com Safety of cloned animal products uncertain - EU agency - Reuters India BRUSSELS (Reuters) - The European Union's top food safety agency said on Thursday cloned animal products may not be safe and further study was needed. "It is clear there are significant animal health and welfare issues for surrogate mothers and Source: in.reuters.com FDA: Avoid jalapenos from Mexico, not US - Boston Globe WASHINGTON— Only jalapeno peppers grown in Mexico seem to be implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican Source: www.boston.com Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18)
Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. CLA approved as food additive - UW Madison CLA approved as food additive - UW Madison
On July 24, the U.S. Food and Drug Administration announced its finding that the food additive conjugated linoleic acid, known as CLA, is "generally regarded as safe" for use in foods. This clears the way for CLA, a healthy type of fat found in meats Source: www.news.wisc.edu Food industry bitten by its own lobbying success - USA Today WASHINGTON (AP) — One of the worst outbreaks of foodborne illness in the U.S. is teaching the food industry the truth of the adage, "Be careful what you wish for because you might get it." The industry pressured the Bush administration years ago to Source: www.usatoday.com Coach says Hardy's test was from 'inadvertent consumption' - Miami Herald SANTA ANA, Calif. World champion swimmer Jessica Hardy is one of at least seven members of the 2008 U.S. Olympic team who are listed as endorsers of a nutritional supplements and sport performance products company whose products have been banned by Source: www.miamiherald.com UPDATE 1-Roche arthritis drug works - US FDA staff - Reuters WASHINGTON, July 25 (Reuters) - Roche Holding AG's (ROG.VX: Quote , Profile , Research , Stock Buzz ) drug Actemra appears to be effective for treating rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday. Food and Drug Source: www.reuters.com Cephalon sues Barr Pharmaceuticals - MSN MoneyCentral Cephalon Inc. said Thursday night it filed a patent infringement lawsuit earlier this week against Barr Pharmaceuticals Inc. and its wholly owned subsidiary, Barr Laboratories Inc., regarding Cephalon's Fentora cancer pain drug. The lawsuit, filed in Source: news.moneycentral.msn.com AP: Food Industry Bitten by Its Lobbying Success - ABC News The industry pressured the Bush administration years ago to limit the paperwork companies would have to keep to help U.S. health investigators quickly trace produce that sickens consumers, according to interviews and government reports reviewed by Source: www.abcnews.go.com Food industry bitten by its lobbying success - Miami Herald WASHINGTON One of the worst outbreaks of foodborne illness in the U.S. is teaching the food industry the truth of the adage, "Be careful what you wish for because you might get it." The industry pressured the Bush administration years ago to limit Source: www.miamiherald.com Roche arthritis drug works, US FDA staff says - Reuters WASHINGTON, July 25 (Reuters) - Roche Holding AG's (ROG.VX: Quote , Profile , Research , Stock Buzz ) drug Actemra appears to be effective for treating rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday. Regarding safety Source: www.reuters.com FDA: Roche's Actemra Appears Effective in Rheumatoid Arthritis - Wall Street Journal Roche Holding AG's Actemra appears effective at treating rheumatoid arthritis, a disease that can destroy joints and causes chronic pain for patients, the U.S. Food and Drug Administration said Friday. The drug appears effective for treating patients Source: online.wsj.com FDA: Roche's Actemra Appears Effective in Rheumatoid Arthritis - Wall Street Journal FDA: Roche's Actemra Appears Effective in Rheumatoid Arthritis - Wall Street Journal
Roche Holding AG's Actemra appears effective at treating rheumatoid arthritis, a disease that can destroy joints and causes chronic pain for patients, the U.S. Food and Drug Administration said Friday. The drug appears effective for treating patients Source: online.wsj.com UPDATE 1-Roche arthritis drug works - US FDA staff - Reuters WASHINGTON, July 25 (Reuters) - Roche Holding AG's (ROG.VX: Quote , Profile , Research , Stock Buzz ) drug Actemra appears to be effective for treating rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday. Food and Drug Source: www.reuters.com Roche arthritis drug works, US FDA staff says - Reuters WASHINGTON, July 25 (Reuters) - Roche Holding AG's (ROG.VX: Quote , Profile , Research , Stock Buzz ) drug Actemra appears to be effective for treating rheumatoid arthritis, U.S. drug reviewers said in a summary released on Friday. Regarding safety Source: www.reuters.com Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Recalls and Safety Alerts: Update on Potentially Contaminated Heparin
Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Herceptin 440 mg Vials and BWFI Diluent Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. FDA Food Protection Plan Shows Significant Progress FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... Avastin (bevacizumab) Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. Electronic Medical Devices Electronic Medical Devices
Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Avastin (bevacizumab) Avastin (bevacizumab)
Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. Grocers stop selling jalapeno peppers after salmonella discovery - Los Angeles Times Grocers stop selling jalapeno peppers after salmonella discovery - Los Angeles Times
Southern California grocery stores reversed themselves Tuesday and started pulling jalapeno peppers from their shelves. The move comes a day after they left the peppers on the shelves even after the Food and Drug Administration said Monday that the Source: www.latimes.com Regulator gives pain medication initial OK - Cincinnati.com NEWPORT - Xanodyne Pharmaceuticals is one step closer to landing approval from the U.S. Food and Drug Administration for its pain medication Zipsor, the Newport-based company said this week. The specialty drug maker said it received an "approvable Source: news.cincinnati.com Amgen blood-clotting drug decision delayed - Boston Globe NEW YORK— Biotechnology company Amgen Inc. said Wednesday the Food and Drug Administration will not issue a much anticipated decision this week on whether to approve an experimental blood-clotting disorder drug. The Thousand Oaks, Calif.-based Source: www.boston.com AP: Food Industry Bitten by Its Lobbying Success - ABC News In this July 17, 2007 file photo, William Hubbard, former Associate Commissioner of the Food and Drug Administration, testifies on Capitol Hill in Washington. Source: www.abcnews.go.com Food industry bitten by its lobbying success - Forbes One of the worst outbreaks of foodborne illness in the U.S. is teaching the food industry the truth of the adage, "Be careful what you wish for because you might get it." The industry pressured the Bush administration years ago to limit the paperwork Source: www.forbes.com Agency: Cloned animal meat may not be safe - MSNBC Jan. 16: On Tuesday, the Food and Drug Administration said that there is no danger from eating cloned cows, pigs and goats. NBC’s Robert Bazelle reports. BRUSSELS - The European Union’s top food safety agency said on Thursday cloned animal Source: www.msnbc.msn.com F.D.A. Urges Genetic Test Before Giving AIDS Drug - Gainesville Sun Seeking to prevent life-threatening side effects, the Food and Drug Administration is urging doctors to use a genetic test to screen patients before prescribing a drug widely used for H.I.V. infection and AIDS. In an advisory it is expected to issue Source: www.gainesville.com Bristol-Myers Squibb and AstraZeneca Submit New Drug Application - MSN MoneyCentral Bristol-Myers Squibb Company BMY and AstraZeneca AZN today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30 th and validation of a Marketing Authorization Application (MAA) to the Source: news.moneycentral.msn.com Profits up, drug makers pledge to cut more jobs - International Herald Tribune Bristol-Myers Squibb and Eli Lilly both reported increases in second-quarter profit and revenue on Thursday and said they planned to cut more jobs. Helped by the weak dollar, both had faster growth in sales overseas but also posted improvements in Source: www.iht.com FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. July 24, 2008Harvard stem cell research gets boost - Boston Globe Harvard stem cell research gets boost - Boston Globe
British drug giant GlaxoSmithKline has agreed to sponsor at least $25 million in work at the Harvard Stem Cell Institute in Cambridge, one of the largest investments in stem cell research ever by a major pharmaceuticals company. As part of the five Source: www.boston.com Tomato Industry Seeks Compensation - Wall Street Journal Federal health officials haven't cleared tomatoes as a cause of the salmonella outbreak that has sickened more than 1,270 nationwide, but the tomato industry has -- and it is asking taxpayers to compensate them for their loss. Rep. Tim Mahoney, a Source: online.wsj.com Lawmakers probe FDA approval of Ranbaxy drugs - Reuters WASHINGTON (Reuters) - Two leading U.S. Democrats said on Tuesday they are investigating whether Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data. The congressional investigation Source: www.reuters.com Amgen: FDA To Miss Wed Decision Deadline On Nplate - CNN Money NEW YORK -(Dow Jones)- The Food and Drug Administration has notified Amgen Inc. (AMGN) that the agency will miss Wednesday's deadline for a decision on approving Nplate, a blood disease treatment. " Amgen continues to work with the FDA to assist in Source: money.cnn.com Sound Pharmaceuticals Files Second IND with the FDA for the Prevention - Forbes SEATTLE, July 23 /PRNewswire/ -- Sound Pharmaceuticals (SPI) has filed an Investigational New Drug Application with the FDA for the clinical testing of a proprietary formulation of ebselen for the prevention of chemotherapy induced hearing loss or Source: www.forbes.com Agency: Cloned animal meat may not be safe - MSNBC Agency: Cloned animal meat may not be safe - MSNBC
Jan. 16: On Tuesday, the Food and Drug Administration said that there is no danger from eating cloned cows, pigs and goats. NBC’s Robert Bazelle reports. BRUSSELS - The European Union’s top food safety agency said on Thursday cloned animal Source: www.msnbc.msn.com Amgen blood-clotting drug decision delayed - CNN Money NEW YORK (Associated Press) - Biotechnology company Amgen Inc. said Wednesday the Food and Drug Administration will not issue a much anticipated decision this week on whether to approve an experimental blood-clotting disorder drug. The Thousand Oaks Source: money.cnn.com Harvard stem cell research gets boost - Boston Globe British drug giant GlaxoSmithKline has agreed to sponsor at least $25 million in work at the Harvard Stem Cell Institute in Cambridge, one of the largest investments in stem cell research ever by a major pharmaceuticals company. As part of the five Source: www.boston.com Amgen says US FDA decision on clot drug delayed - Reuters WASHINGTON, July 23 (Reuters) - The Food and Drug Administration will not rule on Amgen Inc's (AMGN.O: Quote , Profile , Research , Stock Buzz ) experimental clotting disorder drug Nplate by Wednesday's action date, an Amgen spokeswoman said on Source: www.reuters.com GM debate: Cloned meat safe to eat says EU's food agency - Guardian Unlimited Beef and pork produced from healthy cloned cattle and pigs are as safe as meat from conventionally bred animals, the European Food Safety Authority said yesterday. But the EU's food safety agency, giving its long-awaited final scientific opinion on Source: www.guardian.co.uk Bristol-Myers Squibb and AstraZeneca Submit New Drug Application - MSN MoneyCentral Bristol-Myers Squibb Company BMY and AstraZeneca AZN today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 30 th and validation of a Marketing Authorization Application (MAA) to the Source: news.moneycentral.msn.com Ariz. Fry's stores pull jalapeños off shelves - AZCentral.com Arizona Fry's Food Stores pulled raw jalapeños off their shelves Monday night as a precautionary measure after the U.S. Food and Drug Administration reported a recall Monday of jalapeños that were potentially contaminated with salmonella, Fry's Source: www.azcentral.com Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18)
Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. FDA Revises Process for Responding to Drug Applications FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. NexMed Receives FDA Response for ED Product - Forbes NexMed Receives FDA Response for ED Product - Forbes
NexMed, Inc. (Nasdaq: NEXM), today announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major Source: www.forbes.com Lawmakers probe FDA approval of Ranbaxy drugs - Reuters WASHINGTON (Reuters) - Two leading U.S. Democrats said on Tuesday they are investigating whether Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data. The congressional investigation Source: www.reuters.com FDA, CDC back Merck's Gardasil shot as safe - Reuters WASHINGTON (Reuters) - Merck & Co's Gardasil vaccine remains safe and effective for protecting women and girls from a virus that causes cervical cancer, U.S. officials said on Tuesday after reviewing thousands of reports of health problems. Consumers Source: www.reuters.com Bush Administration Opposes Bill Allowing FDA to Regulate Tobacco - FOX News WASHINGTON — The Bush administration strongly opposes legislation to give federal health authorities the power to regulate tobacco products, a top official said in a letter to Congress obtained by The Associated Press on Tuesday. The letter is the Source: www.foxnews.com Genetic test urged before trying AIDS drug - MSNBC WASHINGTON - AIDS patients should have a genetic test before treatment with GlaxoSmithKline Plc's drug Ziagen to see whether they face a higher risk of a potentially fatal reaction, U.S. regulators said on Thursday. For patients who test positive for Source: www.msnbc.msn.com Amgen: FDA To Miss Wed Decision Deadline On Nplate - CNN Money NEW YORK -(Dow Jones)- The Food and Drug Administration has notified Amgen Inc. (AMGN) that the agency will miss Wednesday's deadline for a decision on approving Nplate, a blood disease treatment. " Amgen continues to work with the FDA to assist in Source: money.cnn.com Bristol-Myers, Eli Lilly post strong 2Q results, but Wall Street still - International Herald Tribune TRENTON, New Jersey : Like other major drugmakers, Bristol-Myers Squibb Co. and Eli Lilly & Co. saw benefits from the weak dollar in the second quarter, as sales grew at a faster rate overseas, but both also posted improvements in their U.S Source: www.iht.com Tomato Industry Seeks Compensation - Wall Street Journal Federal health officials haven't cleared tomatoes as a cause of the salmonella outbreak that has sickened more than 1,270 nationwide, but the tomato industry has -- and it is asking taxpayers to compensate them for their loss. Rep. Tim Mahoney, a Source: online.wsj.com Peak Surgical wins FDA approval to market 'tissue dissection - MSN MoneyCentral Peak Surgical Inc., a Palo Alto medical device company, said Thursday it's won Food and Drug Administration clearance to market its proprietary "tissue dissection" system for use in general surgery. The system includes a generator that supplies Source: news.moneycentral.msn.com FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the - Yahoo Finance TITUSVILLE, N.J., July 24 /PRNewswire/ -- Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for TOPAMAX® (topiramate Source: biz.yahoo.com Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19)
The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19)
The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... U.S. urges genetic test before using Glaxo AIDS drug - International Herald Tribune U.S. urges genetic test before using Glaxo AIDS drug - International Herald Tribune
WASHINGTON : AIDS patients should be given a genetic test before treatment with GlaxoSmithKline's drug, Ziagen, to see if they face a higher risk of a potentially fatal reaction, U.S. regulators said on Thursday. For patients who test positive for a Source: www.iht.com UPDATE: Lilly, Bristol 2Q Profits Up On Higher Drug Sales - CNN Money Eli Lilly & Co. (LLY) and Bristol-Myers Squibb Co. (BMY) reported improved second-quarter profits, helped by increased sales of drugs that treat cancer, mental illness and cardiovascular disease. The U.S. drug makers' results also were bolstered by Source: money.cnn.com US urges genetic test with Glaxo AIDS drug - Reuters WASHINGTON, July 24 (Reuters) - AIDS patients should be tested before treatment with GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research , Stock Buzz )(GSK.N: Quote , Profile , Research , Stock Buzz ) AIDS drug Ziagen for a genetic variant that Source: www.reuters.com Serono employee pleads guilty to software charge - Boston Globe A medical director for Serono Laboratories Inc., Norma Muurahainen, pleaded guilty in federal court today to helping distribute medical software to diagnose AIDS wasting, without first winning approval from the Food and Drug Administration. Though Source: www.boston.com U.S. lawmakers probe FDA approval of Ranbaxy drugs - Reuters India WASHINGTON (Reuters) - Two leading U.S. Democrats said on Tuesday they are investigating the Food and Drug Administration's approval of drugs sold by India's Ranbaxy Inc. Reps. John Dingell and Bart Stupak said in a statement they are probing whether Source: in.reuters.com FDA urges genetic test with Glaxo AIDS drug - Reuters WASHINGTON (Reuters) - AIDS patients should be tested before treatment with GlaxoSmithKline Plc's AIDS drug Ziagen for a genetic variant that raises the risk of a potentially fatal reaction, U.S. regulators said on Thursday. For patients who test Source: www.reuters.com Elan says 2Q sales of MS drug surge - MSN MoneyCentral DUBLIN, Ireland (AP) - Biopharmaceutical company Elan Corp. PLC reported narrowing second-quarter losses Thursday as sales surged for its multiple sclerosis-fighting drug, Tysabri. Revenue rose 30 percent to $245.6 million in the April-June quarter Source: news.moneycentral.msn.com Grocery chain Kroger removes jalapenos - BusinessWeek The nation's largest traditional grocery chain has removed jalapeno peppers from its stores as a precaution. Kroger Co. spokeswoman Meghan Glynn said Thursday it decided to halt jalapeno sales after the U.S. Food and Drug Administration reported Source: www.businessweek.com Amgen blood-clotting drug decision delayed - Boston Globe NEW YORK— Biotechnology company Amgen Inc. said Wednesday the Food and Drug Administration will not issue a much anticipated decision this week on whether to approve an experimental blood-clotting disorder drug. The Thousand Oaks, Calif.-based Source: www.boston.com Bush administration opposes tobacco regulation - International Herald Tribune WASHINGTON : The Bush administration strongly opposes legislation to give federal health authorities the power to regulate tobacco products, a top official said in a letter to Congress obtained by The Associated Press on Tuesday. The letter is the Source: www.iht.com Drug maker Elan says 2Q sales grow 30 percent - CNN Money Drug maker Elan says 2Q sales grow 30 percent - CNN Money
NEW YORK (Associated Press) - Biopharmaceutical company Elan Corp. PLC reported growing sales and narrower losses in its second-quarter report Thursday, citing growing momentum for its multiple sclerosis-fighting drug, Tysabri. Sales rose 30 percent Source: money.cnn.com Strong results for drugmakers Lilly and BMS - Financial Times Both Eli Lilly and Bristol-Myers Squibb , two of the biggest pharmaceutical companies in the US, reported an increase in second quarter earnings on Thursday, driven by strong drug sales and a weak dollar that helped drive products overseas. Eli Lilly Source: www.ft.com United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Recall of Nestle Pure Life Purified Water (June 24) This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Drug Shortage: Fentanyl transdermal patch Availability information updated. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall (June 11) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper. FDA Warning: Jalapeños Should Be Pulled From Menus - Eflux Media FDA Warning: Jalapeños Should Be Pulled From Menus - Eflux Media
The Food and Drug Administration announced on Monday it had finally found a contaminated jalapeño pepper grown in Mexico , carrying a strain of salmonella. The discovery took place at a Texas plant, Agricola Zaragoza, a distributor in McAllen Source: www.efluxmedia.com Tainted tomato growers seek aid - St. Petersburg Times TALLAHASSEE — Florida tomato growers want compensation from the federal government for millions of dollars lost because of an investigation that originally focused on raw tomatoes after a salmonella outbreak this spring. Florida Agriculture Source: www.tampabay.com Important Information about Albuterol Metered Dose Inhalers (MDIs) Important Information about Albuterol Metered Dose Inhalers (MDIs)
After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product Product recalled due to the presence of Burkholderia cepacia. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. March 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA says CT scans can cross equipment's signals - Baltimore Sun FDA says CT scans can cross equipment's signals - Baltimore Sun
The Food and Drug Administration is warning doctors and patients that electronic devices such as pacemakers, cardiac defibrillators and insulin pumps can malfunction when people get computerized tomography (CT) scans. The popular scans can cause Source: www.baltimoresun.com PhiloGene, Inc. Announces that VEGFb(TM) has been Granted Orphan Drug - Forbes PhiloGene, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to VEGFb for the treatment of patients with advanced melanoma. This approval is for a larger subset of melanoma patients than was requested Source: www.forbes.com July 23, 2008Ex-Serono medical director pleads guilty, faces jail, fine - Boston Globe Ex-Serono medical director pleads guilty, faces jail, fine - Boston Globe
A former medical director for Serono Laboratories Inc., Norma Muurahainen, pleaded guilty in federal court to helping distribute medical software to diagnose AIDS wasting, without approval from the Food and Drug Administration. Though other employees Source: www.boston.com Living with Fibromyalgia, Drugs Approved to Manage Pain Living with Fibromyalgia, Drugs Approved to Manage Pain
A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Pepper provided hot lead in hunt for salmonella - MSNBC Pepper provided hot lead in hunt for salmonella - MSNBC
WASHINGTON - It was a hot lead for detectives on a cold case. People suddenly were getting salmonella at a Minnesota restaurant more than 1,000 miles from the center of the nation's outbreak. Not my tomatoes, protested the manager. He'd switched his Source: www.msnbc.msn.com Drug maker Lilly to announce 2Q earnings Thursday - CNBC INDIANAPOLIS - Drug maker Eli Lilly and Co. reports second-quarter earnings Thursday before the stock market opens. The following is a summary of key developments related to the period. OVERVIEW: The Food and Drug Administration dealt Lilly a setback Source: www.cnbc.com Pittsburgh cancer institute warns of cell phone-cancer risk, defying - Newsday PITTSBURGH (AP) _ The head of a prominent cancer research institute issued an unprecedented warning to his faculty and staff Wednesday: Limit cell phone use because of the possible risk of cancer. The warning from Dr. Ronald B. Herberman, director of Source: www.newsday.com White House signals it will fight tobacco regulation effort - Los Angeles Times White House signals it will fight tobacco regulation effort - Los Angeles Times
WASHINGTON -- The Bush administration strongly opposes legislation to give the Food and Drug Administration the authority to regulate tobacco products, a top official said in a letter to Congress. The letter is the strongest indication yet that the Source: www.latimes.com Pittsburgh cancer institute warns of cell phone-cancer risk, defying - Newsday PITTSBURGH - The head of a prominent cancer research institute issued an unprecedented warning to his faculty and staff Wednesday: Limit cell phone use because of the possible risk of cancer. The warning from Dr. Ronald B. Herberman, director of the Source: www.newsday.com European Food Safety Authority Reaffirms Science and Safety of - CNBC ARLINGTON, Va., July 23, 2008 /PRNewswire-USNewswire via COMTEX/ -- The American Chemistry Council (ACC) noted today that the European Food Safety Authority (EFSA) reaffirmed the safety of bisphenol A (BPA) in common consumer products such as baby Source: www.cnbc.com INTERVIEW-Wyeth sees big Pristiq sales, despite slow start - Forbes NEW YORK (Reuters) - Wyeth Wednesday said insurers have been more reluctant than expected to reimburse patients for its recently approved Pristiq depression drug, but the company stuck to its forecast of eventual $1 billion-a-year sales for the Source: www.forbes.com Mexico hot under the collar at U.S. pepper scare - San Diego Union-Tribune MEXICO CITY – Mexicans are jumping to the defense of the jalapeno pepper, maligned by U.S. health inspectors in a salmonella scare but loved by millions in its ancient home and growing in popularity north of the border. The U.S. Food and Drug Source: www.signonsandiego.com Merck and Schering-Plough prepare Vytorin letter - Forbes Merck and Schering-Plough prepare Vytorin letter - Forbes
Vytorin partners Merck & Co. and Schering-Plough Corp. have prepared a letter for physicians who might be concerned over recent study results that showed patients taking the cholesterol drug were at higher risk of dying from cancer. The letter Source: www.forbes.com Drug maker Lilly to announce 2Q earnings Thursday - CNBC INDIANAPOLIS - Drug maker Eli Lilly and Co. reports second-quarter earnings Thursday before the stock market opens. The following is a summary of key developments related to the period. OVERVIEW: The Food and Drug Administration dealt Lilly a setback Source: www.cnbc.com Mexico hot under the collar at U.S. pepper scare - San Diego Union-Tribune MEXICO CITY – Mexicans are jumping to the defense of the jalapeno pepper, maligned by U.S. health inspectors in a salmonella scare but loved by millions in its ancient home and growing in popularity north of the border. The U.S. Food and Drug Source: www.signonsandiego.com Stronger Warnings Requested for Fluoroquinolones Stronger Warnings Requested for Fluoroquinolones
FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. FDA, CDC back Gardasil shot as safe - MSNBC FDA, CDC back Gardasil shot as safe - MSNBC
WASHINGTON - Merck & Co’s Gardasil vaccine remains safe and effective for protecting women and girls from a virus that causes cervical cancer, U.S. officials said on Tuesday after reviewing thousands of reports of health problems. Consumers Source: www.msnbc.msn.com Glaxo Braces for Probes, Hires FDA Ex-Litigator - Wall Street Journal GlaxoSmithKline PLC, which is facing various federal and congressional investigations, has hired Daniel Troy, a former chief counsel for the U.S. Food and Drug Administration, as its new general counsel. Mr. Troy, currently a partner at the Source: online.wsj.com A hot (pepper) lead in hunt for salmonella source - Forbes It was a hot lead for detectives on a cold case. People suddenly were getting salmonella at a Minnesota restaurant more than 1,000 miles from the center of the nation's outbreak. Not my tomatoes, protested the manager. He'd switched his supply to Source: www.forbes.com Grocers stop selling jalapeno peppers after salmonella discovery - Los Angeles Times Southern California grocery stores reversed themselves Tuesday and started pulling jalapeno peppers from their shelves. The move comes a day after they left the peppers on the shelves even after the Food and Drug Administration said Monday that the Source: www.latimes.com FDA Approvals: KINRIX and Metvixia CME - Medscape News Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s) ™ for physicians; Family Physicians - up to 0.25 AAFP Prescribed credit(s) for physicians To participate in this internet activity: (1) review the target audience, learning objectives, and Source: www.medscape.com FDA Announces Important Safety-Related Label Update for Ziagen - Phramalive.com ROCKVILLE, Md., July 23, 2008--On July 18, 2008, FDA approved changes to the package insert for Ziagen (abacavir sulfate) highlighting information about the association of the HLA-B*5701 allele (a part of a gene) and hypersensitivity reactions (HSR Source: www.pharmalive.com FDA needs recall authority, group says - Political Gateway WASHINGTON, July 23 (UPI) -- U.S. food stores' mixed reaction to possibly tainted jalapeno and serrano peppers demonstrates the regulators' limited recall authority, a watchdog group says. The U.S. Food and Drug Administration issued warnings last Source: www.politicalgateway.com Bush Administration Opposes FDA Regulation of Tobacco - Wall Street Journal The Bush administration would “strongly oppose” a bill that would give the FDA the power to regulate tobacco, according to a letter Health and Human Services Secretary Mike Leavitt sent to House Republican Joe Barton. The Associated Press Source: blogs.wsj.com Bio-Path Holdings, Inc. Announces Additional Key Personnel Joining Its - Forbes Bio-Path Holdings, Inc. Announces Additional Key Personnel Joining Its - Forbes
Bio-Path Holdings, Inc., a publicly traded biotechnology company with drug development operations in Houston, Texas (Pink Sheets: BPTH), announced today that Dai-Shan Wong, B.S., RAC and Thomas A. Walker, Ph.D. have joined the Company's drug Source: www.forbes.com Amgen says US FDA decision on clot drug delayed - Reuters WASHINGTON, July 23 (Reuters) - The Food and Drug Administration will not rule on Amgen Inc's (AMGN.O: Quote , Profile , Research , Stock Buzz ) experimental clotting disorder drug Nplate by Wednesday's action date, an Amgen spokeswoman said on Source: www.reuters.com Genzyme shares fall on more Myozyme delays - CNBC NEW YORK - Shares of Genzyme Corp. fell Wednesday after the company reported positive second-quarter financial results but said plans to increase production of its genetic disorder drug Myozyme could be further delayed, pending a regulatory review Source: www.cnbc.com New drug prolongs survival of advanced kidney cancer - Reuters UK NEW YORK (Reuters Health) - Treatment with everolimus can significantly improve the progression-free survival of patients with advanced kidney cancer that has not responded to other treatments, according to a report in the online issue of The Lancet Source: uk.reuters.com Mexico hot under the collar at U.S. pepper scare - San Diego Union-Tribune MEXICO CITY – Mexicans are jumping to the defense of the jalapeno pepper, maligned by U.S. health inspectors in a salmonella scare but loved by millions in its ancient home and growing in popularity north of the border. The U.S. Food and Drug Source: www.signonsandiego.com US Cong seeks details of Ranbaxy drug approvals - Business Standard Two United States senators have asked the US Food and Drug Administration (USFDA) to provide details of market approvals given to all medicines sold by India's largest drug-maker Ranbaxy in that country. The senators, John Dingell and Bart Stupak Source: www.business-standard.com Avastin (bevacizumab) Avastin (bevacizumab)
Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Myfortic (mycophenolate acid) Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. Stay Healthy While Traveling Abroad Stay Healthy While Traveling Abroad
Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. July 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Certain lots of both products were recalled because they contained an undeclared ingredient. July 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. Lawmakers probe FDA approval of Ranbaxy drugs - Reuters UK Lawmakers probe FDA approval of Ranbaxy drugs - Reuters UK
WASHINGTON (Reuters) - Two leading U.S. Democrats said on Tuesday they are investigating whether Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data. The congressional investigation Source: uk.reuters.com NexMed Receives FDA Response for ED Product - PR Inside - NexMed, Inc. Mark Westgate, 609-371-8123, ext: 159 CFO mwestgate@nexmed.com or Investor Relations: Rx Communications Group, LLC Paula Schwartz, 917-322-2216 pschwartz@rxir.com NexMed, Inc. (Nasdaq: NEXM), today announced the receipt of a non Source: www.pr-inside.com FDA may ease rule on China seafood - USA Today The Food and Drug Administration may loosen restrictions imposed last year on Chinese seafood processors following recent inspections of some firms in that country, a senior FDA official says. The FDA restricted imports of five types of Chinese Source: www.usatoday.com FDA, CDC back Merck's Gardasil shot as safe - Reuters UK WASHINGTON (Reuters) - Merck & Co's Gardasil vaccine remains safe and effective for protecting women and girls from a virus that causes cervical cancer, U.S. officials said on Tuesday after reviewing thousands of reports of health problems. Consumers Source: uk.reuters.com U.S. lawmakers probe FDA approval of Ranbaxy drugs - Reuters India WASHINGTON (Reuters) - Two leading U.S. Democrats said on Tuesday they are investigating whether Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data. The congressional investigation Source: in.reuters.com Salmonella found in a fresh jalapeno: FDA - Reuters WASHINGTON (Reuters) - The U.S. Food and Drug Administration has found a jalapeno pepper contaminated with a strain of salmonella that has sickened more than 1,200 people, officials said on Monday. The pepper, which showed up at a south Texas Source: www.reuters.com Nation/World briefs - Detroit News WASHINGTON -- A federal rescue of Fannie Mae and Freddie Mac could cost taxpayers $25 billion, congressional budget experts said Tuesday, as lawmakers put finishing touches on legislation that would tap the troubled mortgage giants' profits to help Source: www.detnews.com How Whole Is Whole Grain? - BusinessWeek (page 2 of 2) Of course, how many of those products are made wholly from whole grain is anybody's guess. "The food industry is notorious for making nutrition claims even when reality is far removed from the appearance, and whole grains is a classic Source: www.businessweek.com Alaska House OKs Natural Gas Pipeline Plan - FOX News JUNEAU, Alaska — Alaska's House of Representatives has approved a company's plan to pursue a natural gas pipeline that could unlock 4.5 billion cubic feet of gas reserves a day. The House backed the plan on a 24-16 vote Tuesday. A reconsideration Source: www.foxnews.com Salmonella found on pepper; FDA strengthens warning - CNN WASHINGTON (CNN) -- Investigators had a "significant break" in tracking the salmonella outbreak when they found the bacteria on a jalapeño pepper imported from Mexico at a Texas food supplier, the Food and Drug Administration announced Monday. The Source: www.cnn.com July 22, 2008Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27)
Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. Herceptin 440 mg Vials and BWFI Diluent Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. July 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16)
The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall (June 11) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). FDA Approves First Generic Risperidone to Treat Psychiatric Conditions The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. Broad support in Congress for FDA authority to regulate tobacco - Minneapolis Star Tribune Broad support in Congress for FDA authority to regulate tobacco - Minneapolis Star Tribune
WASHINGTON - The Bush administration strongly opposes legislation to give federal health authorities the power to regulate tobacco products, a top official said in a letter to Congress obtained by The Associated Press on Tuesday. The letter is the Source: www.startribune.com FDA, CDC say Merck's Gardasil shot remains safe - Reuters WASHINGTON (Reuters) - A review of health problems reported after women and girls received Merck & Co's Gardasil vaccine shows it remains safe and effective for protecting against a virus that causes cervical cancer, U.S. officials said on Tuesday. A Source: www.reuters.com NexMed Receives FDA Response for ED Product - Forbes NexMed, Inc. (Nasdaq: NEXM), today announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major Source: www.forbes.com Bush administration opposes tobacco regulation - FOX News WASHINGTON — The Bush administration strongly opposes legislation to give federal health authorities the power to regulate tobacco products, a top official said in a letter to Congress obtained by The Associated Press on Tuesday. The letter is the Source: www.foxnews.com Xanodyne Receives Approvable Letter From the U.S. Food and Drug - Businesswire.com NEWPORT, Ky.--( BUSINESS WIRE )--Xanodyne Pharmaceuticals, Inc. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zipsor, its candidate for the treatment of patients with mild to moderate Source: www.businesswire.com FDA Finds Salmonella Strain In Jalapeno Peppers - CBS 2 Chicago WASHINGTON (CBS News) ― Nearly fifteen weeks after the first salmonella case was reported, investigators found their first infected plant -- not a tomato -- but a jalapeno pepper. And as CBS News correspondent Nancy Cordes reports, this is just the Source: cbs2chicago.com FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. Drug Shortage: Fentanyl transdermal patchUnited States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Across the nation: Blackwater out of security biz - Detroit Free Press Across the nation: Blackwater out of security biz - Detroit Free Press
Blackwater Worldwide executives said Monday that they plan to move out of security contracting because government scrutiny and negative attention have made the business too costly. "The experience we've had would certainly be a disincentive to any Source: www.freep.com Tranzyme Pharma Receives Notices of Allowance from USPTO on Two - Forbes Tranzyme Pharma, a leading biopharmaceutical company developing novel mechanism-based therapeutics for the treatment of gastrointestinal (GI) and metabolic disorders, announced today that the Company has received Notices of Allowance from the U.S Source: www.forbes.com Officials warn of eating raw jalapeno and serrano peppers - Atlanta Journal Constitution Federal officials investigating a widespread salmonella outbreak have found the smoking pepper. A jalapeno pepper contaminated with the same strain of salmonella that has caused the outbreak was found in a food distribution warehouse in McAllen Source: www.ajc.com Big Pharma: What Safe Haven? - BusinessWeek by Arlene Weintraub Pharmaceutical stocks have been rallying of late, buoyed by news of richly priced mergers, including Roche's $44 billion bid for Genentech ( DNA ) on July 21 and the $7 billion offer by generic drugmaker Teva Pharmaceutical Source: www.businessweek.com Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. July 21, 2008FDA Confirms Jalapeños As a Source of Salmonella Outbreak - Wall Street Journal FDA Confirms Jalapeños As a Source of Salmonella Outbreak - Wall Street Journal
After weeks of searching, federal regulators have found a smoking gun in the salmonella outbreak originally blamed on tomatoes: a jalapeño pepper contaminated with the rare Saintpaul strain of salmonella. The positive sample was found in a Mexican Source: online.wsj.com FDA: Salmonella found in jalapeno - Chicago Tribune WASHINGTON - Call it the smoking jalapeno. After nearly two months of mystery, the Food and Drug Administration has finally identified a piece of produce—a jalapeno pepper—that is contaminated with the same strain of salmonella that has sickened Source: www.chicagotribune.com Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product Product recalled due to the presence of Burkholderia cepacia. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Recall of Nestle Pure Life Purified Water (June 24) Recall of Nestle Pure Life Purified Water (June 24)
This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size. FDA Approves First Generic Risperidone to Treat Psychiatric Conditions The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Wrinkle Relief: Injectable Cosmetic Fillers Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done. UPDATE 2-Salmonella found in fresh jalapeno, U.S. FDA says - Reuters UPDATE 2-Salmonella found in fresh jalapeno, U.S. FDA says - Reuters
WASHINGTON, July 21 (Reuters) - The U.S. Food and Drug Administration has found a jalapeno pepper contaminated with a strain of salmonella that has sickened more than 1,200 people, officials said on Monday. The pepper, which showed up at a south Source: www.reuters.com UPDATE 2-Salmonella found in fresh jalapeno, U.S. FDA says - Reuters UPDATE 2-Salmonella found in fresh jalapeno, U.S. FDA says - Reuters
WASHINGTON, July 21 (Reuters) - The U.S. Food and Drug Administration has found a jalapeno pepper contaminated with a strain of salmonella that has sickened more than 1,200 people, officials said on Monday. The pepper, which showed up at a south Source: www.reuters.com FDA finds salmonella strain in jalapeno pepper - Boston Globe WASHINGTON— Government inspectors finally have a big clue in the nationwide salmonella outbreak: They found the same bacteria on a single Mexican-grown jalapeno pepper handled by a small Texas produce shipper. But Monday's discovery doesn't solve Source: www.boston.com Salmonella found on pepper; FDA strengthens warning - CNN WASHINGTON (CNN) -- Investigators had a "significant break" in tracking the salmonella outbreak when they found the bacteria on a jalapeño pepper imported from Mexico at a Texas food supplier, the Food and Drug Administration announced Monday. The Source: www.cnn.com Pathway device wins FDA approval - Seattle Times U.S. regulators have approved Pathway Medical Technology's first commercial product, a medical device that unclogs leg arteries, the Web site Xconomy reported today. The product still won't be available for sale because the Kirkland company has to Source: seattletimes.nwsource.com Salmonella found in a fresh jalapeno, FDA says - Reuters WASHINGTON (Reuters) - The U.S. Food and Drug Administration has found a jalapeno pepper contaminated with a strain of salmonella that has sickened more than 1,200 people, officials said on Monday. The pepper, which showed up at a south Texas Source: www.reuters.com FDA Finds Salmonella in Jalapeño - Time (WASHINGTON) — Government inspectors have found the same salmonella strain responsible for a nationwide food-poisoning outbreak in a Mexican-grown jalapeño in a Texas plant, prompting a new warning for consumers to avoid eating fresh jalapeños Source: www.time.com FDA links salmonella to jalapeños - MSNBC WASHINGTON - U.S. government inspectors have found the same salmonella strain responsible for a food-poisoning outbreak in the U.S. in a Mexican-grown jalapeno pepper in a Texas plant, prompting a new warning for consumers to avoid eating fresh Source: www.msnbc.msn.com FDA finds salmonella strain in Mexican-grown jalapeno in a Texas plant - Minneapolis Star Tribune Uhhhh wans;t there a law passed a few years ago that mandated tracking of where produce comes from? How come the FDA hasn't implemented … read more a valid tracling system of where our food comes from? I am really glad the terrorists haven't Source: www.startribune.com Salmonella found in fresh jalapeno, FDA says - Reuters Salmonella found in fresh jalapeno, FDA says - Reuters
WASHINGTON (Reuters) - The U.S. Food and Drug Administration has found a jalapeno pepper contaminated with a strain of salmonella that has sickened more than 1,200 people, officials said on Monday. The pepper, which showed up at a south Texas Source: www.reuters.com UPDATE 2-Salmonella found in fresh jalapeno, U.S. FDA says - Reuters WASHINGTON, July 21 (Reuters) - The U.S. Food and Drug Administration has found a jalapeno pepper contaminated with a strain of salmonella that has sickened more than 1,200 people, officials said on Monday. The pepper, which showed up at a south Source: www.reuters.com FDA Finds Salmonella Strain in Jalapeno Pepper - The Ledger WASHINGTON | Government inspectors finally have a big clue in the nationwide salmonella outbreak: They found the same bacteria on a single Mexican-grown jalapeno pepper handled by a small Texas produce shipper. But Monday’s discovery doesn’t Source: www.theledger.com Pathway device wins FDA approval - Seattle Times U.S. regulators have approved Pathway Medical Technology's first commercial product, a medical device that unclogs leg arteries, the Web site Xconomy reported today. The product still won't be available for sale because the Kirkland company has to Source: seattletimes.nwsource.com FDA Clears Osmetech's Warfarin Sensitivity Test and New eSensor(R) XT - Forbes Osmetech plc (AIM:OMH), the fast growing international molecular diagnostics company, announces that it has received 510(k) clearance from the US Food & Drug Administration ('FDA') for its eSensor Warfarin Sensitivity Test to be used as an aid in the Source: www.forbes.com Legal Questions Still Dogging Wyeth - Street.Com Legal Questions Still Dogging Wyeth - Street.Com
From Wyeth WYE and diet drugs, to Merck MRK and Vioxx to Eli Lilly LLY and Zyprexa, companies are forced to make careful calculations about mass product-liability lawsuits. No easy answers exist. Wyeth, or example, has set aside some $21.1 billion Source: www.thestreet.com Uroplasty Joins National Association For Continence's Industry Council - MSN MoneyCentral MINNEAPOLIS , July 21 /PRNewswire-FirstCall/ -- Uroplasty, Inc. UPI , a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunction, today announced that it has become a Source: news.moneycentral.msn.com The Next Big Thing - ABC News Let's face it: We spend an awful lot of our time waiting. Waiting in bathroom lines. Waiting for that hot Kenneth Cole leather clutch to go on sale at the end of the season. Waiting for a decent Dane Cook movie. From female Viagra to male birth Source: www.abcnews.go.com Recap of Saturday, July 19 - FOX News This past week's "Bulls & Bears": Gary B. Smith, Exemplar Capital; Tobin Smith, ChangeWave Research; Eric Bolling, FOX Business News; Peter Schiff, Euro Pacific Capital; Matt McCall, Penn Financial, and Maria Cardona, Democratic strategist. Gary B Source: www.foxnews.com Tomatoes back on menu after 'not guilty' in salmonella outbreak - Guardian Unlimited America's tomato industry has begun the process of recovering up to $200m (£100m) from the US government in lost revenues caused by the fruit being falsely blamed for a major salmonella outbreak . On Thursday, after seven weeks under investigation Source: www.guardian.co.uk FDA may ease rule on China seafood - USA Today The Food and Drug Administration may loosen restrictions imposed last year on Chinese seafood processors following recent inspections of some firms in that country, a senior FDA official says. The FDA restricted imports of five types of Chinese Source: www.usatoday.com FDA issues guidance on antioxidants - Food Navigator The Small Entity Compliance Guide sets out the agency's position "in plain language" regarding the use of the nutrient content claims on dietary supplement products. It reiterates FDA's amended regulations published on September 23 1997 in the Source: www.foodnavigator-usa.com UK small close higher; Goldplat up on strong trading update - CNBC LONDON (Thomson Financial) - UK small caps' upward momentum couldn't be stifled by close of trade, with the wider markets also ticking higher, as Goldplat soared on the back of a trading update. At the close, the FTSE small cap index was up 55.10 Source: www.cnbc.com Exelixis shares rise as late-stage study begins - CNN Money NEW YORK (Associated Press) - Shares of biotechnology company Exelixis Inc. rose Monday after the company said it started a late-stage study on its potential thyroid cancer drug. The stock rose 29 cents, or 4.7 percent, to $6.44 in afternoon trading Source: money.cnn.com FDA Clears Osmetech's Warfarin Sensitivity Test and New eSensor(R) XT - Forbes Osmetech plc (AIM:OMH), the fast growing international molecular diagnostics company, announces that it has received 510(k) clearance from the US Food & Drug Administration ('FDA') for its eSensor Warfarin Sensitivity Test to be used as an aid in the Source: www.forbes.com Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9)
LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. FDA: Older psych drugs have fatal risks in seniors - Associated Press FDA: Older psych drugs have fatal risks in seniors - Associated Press
WASHINGTON (AP) -- The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia can increase their risk of death. Antipsychotic drugs are approved to treat Source: hosted.ap.org The National Hemophilia Foundation Appoints Advocacy Leader as New CEO - MSN MoneyCentral NEW YORK , July 21 /PRNewswire/ -- The National Hemophilia Foundation (NHF) announced the appointment of Val D. Bias as its Chief Executive Officer. As CEO, Mr. Bias will direct NHF's ongoing efforts to reorganize and unify the national chapter Source: news.moneycentral.msn.com Tomatoes back on menu after 'not guilty' in salmonella outbreak - Guardian Unlimited America's tomato industry has begun the process of recovering up to $200m (£100m) from the US government in lost revenues caused by the fruit being falsely blamed for a major salmonella outbreak . On Thursday, after seven weeks under investigation Source: www.guardian.co.uk Family sues co. for muscular dystrophy drug - Associated Press WASHINGTON (AP) -- A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Source: hosted.ap.org FDA May Ease Rule on China Seafood - Redorbit.com The Food and Drug Administration may loosen restrictions imposed last year on Chinese seafood processors following recent inspections of some firms in that country, a senior FDA official says. The FDA restricted imports of five types of Chinese Source: www.redorbit.com Inion Receives 510(k) Marketing Clearance to Sell its Biodegradable - MSN MoneyCentral TAMPERE, Finland and GUILDFORD, England , July 21 /PRNewswire/ -- Inion (LSE: IIN), the company focused on the development and commercialisation of novel biodegradable medical implants, today announces it has received 510(k) marketing clearance from Source: news.moneycentral.msn.com Children treated abroad as U.S. doctors push for devices - Reuters CHICAGO (Reuters) - Every year, Chicago-based cardiologist Ziyad Hijazi accompanies two or three children and their families to his native Jordan for heart operations using medical devices that are not approved in the United States. In one such case Source: www.reuters.com LegalView Launches Revamped Ketek Information Portal with Details of - Transworld News LegalView Launches Revamped Ketek Information Portal with Details of the Drug's Potential Risks Denver, CO 7/21/2008 05:54 AM GMT (FINDITT) LegalView, the best legal resource available on the Web, announced its newly revamped Ketek information portal Source: www.transworldnews.com US to help India on drug regulation - Livemint.com Discussions between the Drug Controller General of India, or DCGI and the US Food and Drug Administration, or FDA, also cover clinical practices and biological drugs and are expected to strengthen the regulatory capacity of the Indian agency in Source: www.livemint.com FDA Rule and Companion Guidance Make Early Stage Clinical Drug - WebWire The U.S. Food and Drug Administration today issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA Source: www.webwire.com Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. Drug Shortage: MVI Adult Injectable Hospira information updated. Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... F.D.A. Lifts Tomato Warning - The Ledger F.D.A. Lifts Tomato Warning - The Ledger
The Food and Drug Administration revoked its warning against eating certain kinds of raw tomatoes Thursday, even though officials said they had yet to pinpoint the source of the nation’s largest foodborne outbreak in the last decade. Meanwhile, the Source: www.theledger.com Officials investigating anti-smoking drug study - The Washington Times Officials with the Department of Veterans Affairs are preparing to determine who was at fault for failing to quickly notify participants in a smoking-cessation study about the potentially dangerous side effects of a drug they were prescribed and Source: washingtontimes.com Invisibility element of 2 new developments - Chicago Tribune A small Skokie -based technology company is targeting the multibillion-dollar counterfeit drug business by being able to identify every manufactured capsule, tablet and vial. "We can encode a million tablets in an eight-hour shift without slowing Source: www.chicagotribune.com Needed: quality control on blood - Kansas City Star The Red Cross blood supply is thought to be one of the safest in the world. Yet the organization’s failure to correct significant shortcomings continues to frustrate regulators. Earlier this year, the commissioner of the U.S. Food and Drug Source: www.kansascity.com Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27)
Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Ask Dr. H: A puzzling aspect of age and a swelling prostate - Philadelphia Inquirer Ask Dr. H: A puzzling aspect of age and a swelling prostate - Philadelphia Inquirer
Question: If a man's testosterone level decreases as he gets older, why doesn't the prostate get smaller with age rather than developing BPH? Answer: That's because testosterone is not the main driving force behind BPH (Benign Prostatic Hyperplasia Source: www.philly.com Italy Stocks Update: Impregilo, Italease, Montanari, Saipem - Bloomberg July 21 (Bloomberg) -- Italy's S&P/MIB Index declined for the first time in four sessions, losing 165, or 0.6 percent, to 27,935. Futures expiring in September slipped 113, or 0.4 percent, to 28,180. The following were among the most active stocks on Source: www.bloomberg.com Wal-Mart: the new FDA - Tehran Times The question is, why? Bisphenol-A has been widely used since the 1950s. The Food and Drug Administration, as well as Japanese and European regulators, have no problems with it. Canada is about to ban it from baby bottles, but officials term the move Source: www.tehrantimes.com Counterfeit drugs proliferate on Internet - United Press International BALTIMORE, July 21 (UPI) -- The U.S. Food and Drug Administration has been struggling as it tries to deal with rogue Internet sites that sell medications, a researcher says. Francis Palumbo of the University of Maryland School of Pharmacy, the author Source: www.upi.com Ranbaxy probe highlights medical issues - Financial Times When US regulators raised concerns during their visit to a factory operated by Ranbaxy , the Indian generic drugs group, no one involved imagined that their inquiry would last so long, become so public or raise the stakes so high. Since an inspection Source: www.ft.com FDA may ease rule on China seafood - USA Today The Food and Drug Administration may loosen restrictions imposed last year on Chinese seafood processors following recent inspections of some firms in that country, a senior FDA official says. The FDA restricted imports of five types of Chinese Source: www.usatoday.com UK small caps open firmer; ViaLogy up on oil reservoir update - Forbes LONDON (Thomson Financial) - UK small caps were firmer in early trade, bucking the weaker trend of the wider market, with ViaLogy out in front on the back of an oil reservoir update. The FTSE Small Cap index was 3.90 points ahead at 2,680.10 by 9.05 Source: www.forbes.com Dr. Flemming Ornskov Nominated for Election as Chairman of the - MSN MoneyCentral HAMBURG, Germany, July 21, 2008 (PRIME NEWSWIRE) -- Evotec AG (Frankfurt:EVT) (Nasdaq:EVTC) announced today that at its July 9, 2008 meeting the Supervisory Board of Evotec AG decided to propose the election of Dr. Flemming Ornskov to the Supervisory Source: news.moneycentral.msn.com Food safety first - AZCentral.com The search for the source of salmonella poisoning that sickened more than 800 people in the past two months demonstrates the importance of dealing with several inadequacies in our food inspection system. To be honest, calling it a "system" is overly Source: www.azcentral.com AS Roma, Edison, Pirelli, Telecom Italia: Italy Equity Preview - Bloomberg July 20 (Bloomberg) -- The following is a list of companies whose shares may have unusual price changes in Italy. Stock symbols are in parentheses after company names. Share prices are from the last close. The S&P/MIB Index added 432, or 1.6 percent Source: www.bloomberg.com Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14)
Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9) Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). July 20, 2008FDA: Tomatoes are safe - Detroit News FDA: Tomatoes are safe - Detroit News
WASHINGTON -- It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday -- lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still Source: www.detnews.com Food safety first - AZCentral.com The search for the source of salmonella poisoning that sickened more than 800 people in the past two months demonstrates the importance of dealing with several inadequacies in our food inspection system. To be honest, calling it a "system" is overly Source: www.azcentral.com FDA decides it's safe to eat tomatoes - Boston Globe WASHINGTON - It's OK to eat all kinds of tomatoes again, the US government declared yesterday - lifting its salmonella warning on the summer favorites amid signs the record outbreak, while not over, may finally be slowing. Hot peppers still get a Source: www.boston.com US lawmakers to probe FDA's role in Ranbaxy row - Times of India WASHINGTON: Two senior lawmakers in the US House of Representatives have said that they will probe what the American regulators knew about allegations that the Indian pharma major Ranbaxy lied about the quality of its products. This follows the US Source: timesofindia.indiatimes.com Wal-Mart: the new FDA - Tehran Times The question is, why? Bisphenol-A has been widely used since the 1950s. The Food and Drug Administration, as well as Japanese and European regulators, have no problems with it. Canada is about to ban it from baby bottles, but officials term the move Source: www.tehrantimes.com Editorial: Make food traceable from farm to table - Roanoke Times A food-borne salmonella outbreak so far has sickened more than 1,220 people in 42 states, the District of Columbia and Canada. Source: unknown. Weeks after the Food and Drug Administration issued its first warning, it still isn't certain what in the Source: www.roanoke.com Wal-Mart: the new FDA - Tehran Times Wal-Mart: the new FDA - Tehran Times
The question is, why? Bisphenol-A has been widely used since the 1950s. The Food and Drug Administration, as well as Japanese and European regulators, have no problems with it. Canada is about to ban it from baby bottles, but officials term the move Source: www.tehrantimes.com Red Cross told to fix blood collection or face charges - Houston Chronicle For 15 years, the American Red Cross has been under a federal court order to improve the way it collects and processes blood. Yet, despite $21 million in fines since 2003 and repeated promises to follow procedures intended to ensure the safety of Source: www.chron.com FDA To Develop Pipeline Of Scientists, Other Professionals - eMaxHealth.com The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. The FDA Commissioner’s Fellowship Program will provide Source: www.emaxhealth.com FDA may ease rule on China seafood - USA Today The Food and Drug Administration may loosen restrictions imposed last year on Chinese seafood processors following recent inspections of some firms in that country, a senior FDA official says. The FDA restricted imports of five types of Chinese Source: www.usatoday.com 60 Minutes - CBS News Darfur, Venezuela, Cancer Research | 07/20/2008 60 Minutes Correspondent Scott Pelley crosses over the border from Chad into Sudan in search of a boy displaced during ongoing ethnic cleansing in Darfur. 60 Minutes Correspondent Lesley Stahl reports Source: www.cbsnews.com Food safety first - AZCentral.com The search for the source of salmonella poisoning that sickened more than 800 people in the past two months demonstrates the importance of dealing with several inadequacies in our food inspection system. To be honest, calling it a "system" is overly Source: www.azcentral.com FDA declares it's OK to eat tomatoes again - Miami Herald It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday - lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Obama's trip: 1st high-profile Source: www.miamiherald.com Downsizing government to death - Los Angeles Times Last week, consumers were worried about salmonella in their fresh tomatoes. Before that, it was E. coli in their spinach. Something is wrong. Eating a salad is not supposed to be a high-risk activity But the problem isn't so much farmers. It's Source: www.latimes.com PEOPLE'S PHARMACY - Houston Chronicle When automobiles started showing up on America's streets, a lot of people were skeptical. Cars were noisy and unreliable, and many people thought they were just a passing fancy. Within a few decades, though, cars ruled the roads. Those with horse Source: www.chron.com Needed: quality control on blood - Kansas City Star Needed: quality control on blood - Kansas City Star
The Red Cross blood supply is thought to be one of the safest in the world. Yet the organization’s failure to correct significant shortcomings continues to frustrate regulators. Earlier this year, the commissioner of the U.S. Food and Drug Source: www.kansascity.com F.D.A. Lifts Tomato Warning - The Ledger The Food and Drug Administration revoked its warning against eating certain kinds of raw tomatoes Thursday, even though officials said they had yet to pinpoint the source of the nation’s largest foodborne outbreak in the last decade. Meanwhile, the Source: www.theledger.com Salmonella scare hit state growers hard - San Francisco Gate By the time the Food and Drug Administration cleared tomatoes Thursday in its investigation of a salmonella outbreak, California's tomato sales had plummeted more than 40 percent. "It's a government-made disaster," said Melanie Horwath, office Source: www.sfgate.com Officials investigating anti-smoking drug study - The Washington Times Officials with the Department of Veterans Affairs are preparing to determine who was at fault for failing to quickly notify participants in a smoking-cessation study about the potentially dangerous side effects of a drug they were prescribed and Source: washingtontimes.com Rash Redux - Time Young doctors spend a lot of time solving medical mysteries, and one of the more memorable ones I encountered occurred in the 1990s, when I was a resident in neurosurgery at the University of Michigan. A woman in her mid-60s came to our clinic Source: time.com Up Next - CBS News SEARCHING FOR JACOB - Jacob fled his village in Darfur to escape mass murder, leaving his family and schoolbooks behind. Scott Pelley puts a face on the horrible genocide in Sudan when he tracks down Jacob to return his books. Shawn Efran is the Source: www.cbsnews.com Invisibility element of 2 new developments - Chicago Tribune A small Skokie -based technology company is targeting the multibillion-dollar counterfeit drug business by being able to identify every manufactured capsule, tablet and vial. "We can encode a million tablets in an eight-hour shift without slowing Source: www.chicagotribune.com Update: FDA Says Tomatoes Not Linked to Salmonella Outbreak - Eflux Media Update: FDA Says Tomatoes Not Linked to Salmonella Outbreak - Eflux Media
The U.S. Food and Drug Administration announced Thursday, July 17, that it has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak of Salmonella Saintpaul. The statement also removes the Source: www.efluxmedia.com Funding woes threaten future drug development, finds new reserach - Cambridge Network Risk aversion from investors is posing a serious threat to drug development, according to the latest annual biotechnology report by Marks & Clerk, one of the world's leading firms of patent and trade mark attorneys. * 82 per cent of executives Source: www.cambridgenetwork.co.uk FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. Promising therapy for 'eye stroke' - Baltimore Sun Promising therapy for 'eye stroke' - Baltimore Sun
At first, Christine Jablonski didn't worry about the blurry vision in her right eye. She dismissed it as a flake of morning mascara and went about her daily business in Ellicott City . But within two hours, the eye went dark. She rushed to Johns Source: www.baltimoresun.com FDA panel gives mixed review of J&J antibiotic - San Diego Union-Tribune WASHINGTON – Government experts narrowly backed a Johnson & Johnson antibiotic as a treatment against pneumonia Wednesday, despite serious concerns about how the company studied the drug. A Food and Drug Administration panel of antibiotic experts Source: www.signonsandiego.com FDA declares it's OK to eat tomatoes again - Boston Globe WASHINGTON— It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday -- lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still Source: www.boston.com Celera gets FDA approval for diagnostic software - CNBC ALAMEDA, Calif. - Molecular diagnostics company Celera Corp. said Friday the Food and Drug Administration approved new system software used for HIV monitoring and treatment. The new software for the ViroSeq HIV-1 Genotyping system is designed to Source: www.cnbc.com FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Children treated abroad as U.S. doctors push for devices - Reuters Children treated abroad as U.S. doctors push for devices - Reuters
CHICAGO (Reuters) - Every year, Chicago-based cardiologist Ziyad Hijazi accompanies two or three children and their families to his native Jordan for heart operations using medical devices that are not approved in the United States. In one such case Source: www.reuters.com Food safety - Miami Herald Consumers can start eating all types of tomatoes again without worries about getting sick. The Food and Drug Administration on Thursday lifted its salmonella warnings on tomatoes, while advising at risk consumers to limit their consumption of fresh Source: www.miamiherald.com Tomato growers: Salmonella scare damages industry - Chicago Sun-Times RICHMOND, Va.---- The 6,000 acres of tomatoes grown on Virginia's sea-swept Eastern Shore were never implicated in the national salmonella outbreak -- they were still on the vine weeks after people starting getting sick. Still, that hasn't made much Source: www.suntimes.com China has 64,000 drug supervision officials - Xinhua News Agency BEIJING, July 18 (Xinhua) -- China reported 64,000 drug supervision officials working for 2,692 drug regulatory departments by the end of 2007, said a white paper published on Friday by the Information Office of the State Council. Meanwhile, China Source: news.xinhuanet.com China denies Olympic ban on drug sales - Guardian Unlimited BEIJING, July 18 (Reuters) - China denied on Friday that pharmacies had banned the sale of everyday products such as cold medication and rash cream to prevent accidental doping during the Olympics, and sought to assure that drugs would meet standards Source: www.guardian.co.uk CDC and FDA are wearing a little tomato on their face - Herald Tribune Take the tomato industry, or what is left of it in Florida. Everyone wants the Centers for Disease Control and the Food and Drug Administration to keep us healthy and protect our food supply. Source: www.heraldtribune.com CDC and FDA are wearing a little tomato on their face - Herald Tribune There are limits on free speech. Hollering fire in a crowded theater is perhaps the better known one. There should be another. Take the tomato industry, or what is left of it in Florida. Everyone wants the Centers for Disease Control and the Food and Source: www.heraldtribune.com Anti-smoking drug study investigated - Washington Times Officials with the Department of Veterans Affairs are preparing to determine who was at fault for failing to quickly notify participants in a smoking-cessation study about the potentially dangerous side effects of a drug they were prescribed and Source: www.washtimes.com Tomatoes languish on nation's vines - Detroit Free Press RICHMOND, Va. -- The 6,000 acres of tomatoes grown on Virginia's sea-swept eastern shore were never implicated in the national salmonella outbreak -- they were still on the vine weeks after people starting getting sick. Still, that hasn't made much Source: www.freep.com FEATURE-U.S. doctors push for medical devices for children - Forbes CHICAGO (Reuters) - Every year, Chicago-based cardiologist Ziyad Hijazi accompanies two or three children and their families to his native Jordan for heart operations using medical devices that are not approved in the United States. In one such case Source: www.forbes.com FDA Approves New Genetic Test for Patients with Breast Cancer FDA Approves New Genetic Test for Patients with Breast Cancer
The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product Product recalled due to the presence of Burkholderia cepacia. April 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. Living with Fibromyalgia, Drugs Approved to Manage Pain Living with Fibromyalgia, Drugs Approved to Manage Pain
A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Making Sense of Vytorin Concerns This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Your Guide to Reporting Problems to FDA This guide provides tips and a quick-reference chart to help you report a problem to FDA. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... China denies Olympic ban on drug sales - Guardian Unlimited China denies Olympic ban on drug sales - Guardian Unlimited
BEIJING, July 18 (Reuters) - China denied on Friday that pharmacies had banned the sale of everyday products such as cold medication and rash cream to prevent accidental doping during the Olympics, and sought to assure that drugs would meet standards Source: www.guardian.co.uk CDC and FDA are wearing a little tomato on their face - Herald Tribune Take the tomato industry, or what is left of it in Florida. Everyone wants the Centers for Disease Control and the Food and Drug Administration to keep us healthy and protect our food supply. Source: www.heraldtribune.com Children treated abroad as U.S. doctors push for devices - Reuters CHICAGO (Reuters) - Every year, Chicago-based cardiologist Ziyad Hijazi accompanies two or three children and their families to his native Jordan for heart operations using medical devices that are not approved in the United States. In one such case Source: www.reuters.com Tomato growers: Salmonella scare damages industry - Chicago Sun-Times RICHMOND, Va.---- The 6,000 acres of tomatoes grown on Virginia's sea-swept Eastern Shore were never implicated in the national salmonella outbreak -- they were still on the vine weeks after people starting getting sick. Still, that hasn't made much Source: www.suntimes.com Downsizing government to death - Los Angeles Times Last week, consumers were worried about salmonella in their fresh tomatoes. Before that, it was E. coli in their spinach. Something is wrong. Eating a salad is not supposed to be a high-risk activity But the problem isn't so much farmers. It's Source: www.latimes.com Tomatoes languish on nation's vines - Detroit Free Press RICHMOND, Va. -- The 6,000 acres of tomatoes grown on Virginia's sea-swept eastern shore were never implicated in the national salmonella outbreak -- they were still on the vine weeks after people starting getting sick. Still, that hasn't made much Source: www.freep.com Food safety - Miami Herald Consumers can start eating all types of tomatoes again without worries about getting sick. The Food and Drug Administration on Thursday lifted its salmonella warnings on tomatoes, while advising at risk consumers to limit their consumption of fresh Source: www.miamiherald.com China has 64,000 drug supervision officials - Xinhua News Agency BEIJING, July 18 (Xinhua) -- China reported 64,000 drug supervision officials working for 2,692 drug regulatory departments by the end of 2007, said a white paper published on Friday by the Information Office of the State Council. Meanwhile, China Source: news.xinhuanet.com Avastin (bevacizumab) Avastin (bevacizumab)
Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. Drug Shortage: MVI Adult Injectable Hospira information updated. |
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