September 27, 2008Infant Formula Manufactured in China Infant Formula Manufactured in China
FDA issues Health Information Advisory due to reports of contamination with melamine. Tarceva (erlotinib) Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures
The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications. Trans Ocean Products Recalls Cracked Pepper Style Smoked Salmon LOT No 54933-2 Because of Possible Health Risks (August 29) Trans-Ocean Products, Inc. of Bellingham, Washington is recalling its 4 ounce Cracked Pepper Style Smoked Salmon Lot No 54933-2 because it has 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. T. Marzetti Company Recalls a Limited Number of Girard's Honey Dijon Peppercorn (September 4) T. Marzetti Company is recalling a limited number of 12 fl. oz. bottles of Girard's Honey Dijon Peppercorn (item 58105) because they may have the incorrect back label of Girard's French Dressing (item 58015). The Girard's Honey Dijon Peppercorn contains eggs, which is not declared as an ingredient on the Girard's French label. People who have allergies to egg run the risk of serious allergic reaction if they consume this product. FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. FDA label doesn't quash drug suit, court says - San Francisco Gate FDA label doesn't quash drug suit, court says - San Francisco Gate
Saturday, September 27, 2008 A Californian who is harmed by prescription drugs can sue the manufacturer for failing to warn of potential dangers, even if the product had a federally approved label, a state appeals court has ruled. Tackling an issue Source: www.sfgate.com FDA to Review Anemia Drug Eprex Following High Rate of Deaths in Study - Eflux Media The Food and Drug Administration announced on Friday that they are reviewing a higher rate of deaths among patients given Johnson & Johnson anemia drug Eprex in a German study involving stroke patients. The study was testing if the drug could improve Source: www.efluxmedia.com Report: FDA lax in oversight of produce industry - Fosters Daily Democrat FRESNO, Calif. (AP) _ The Food and Drug Administration's efforts to combat food-borne illness are hampered by staffing shortages, infrequent inspections and lax enforcement at fresh produce processing plants, according to congressional investigators Source: www.fosters.com FDA faulted for produce oversight - Reuters India WASHINGTON (Reuters) - Preparations for a biological attack and repeated outbreaks of food poisoning have interfered with efforts by the U.S. Food and Drug Administration to improve the safety of fresh produce, according to a report released on Source: in.reuters.com GAO: FDA lax in produce oversight - USA Today FRESNO, Calif. (AP) — The Food and Drug Administration's efforts to combat food-borne illness are hampered by infrequent inspections, not enough staff and the failure to implement a program devoted to the safety of fresh produce, according to Source: www.usatoday.com GAO Report: FDA Fails to Protect Americans against Food-Borne Illness - Eflux Media A report made public on Friday reveals that the Food and Drug Administration’s capability to protect Americans against food-borne illnesses is hampered by staffing shortages, infrequent inspections and lax enforcement at fresh produce processing Source: www.efluxmedia.com Cypress Bioscience up ahead of FDA action date - CNBC WASHINGTON - Shares of Cypress Bioscience jumped Thursday as the deadline for an approval decision on the company's lead product draws closer. The Food and Drug Administration is scheduled to make a ruling next month on milnacipran, a drug developed Source: www.cnbc.com Indevus shares double on deals with FDA, Teva - MSN MoneyCentral NEW YORK (AP) - Shares of Indevus Pharmaceuticals Inc. more than doubled Friday after the company said it is collaborating with Teva Pharmaceutical Industries Ltd. to develop a treatment for stuttering and could move forward with its delayed Source: news.moneycentral.msn.com BRIEF-Boston Scientific announces FDA approval - Forbes Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Source: www.forbes.com September 26, 2008FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA Requires Stronger Fungal Infection Warning for TNF Blockers
FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. The Hershey Company Announces Nationwide Voluntary Recall of Hershey's Chocolate Shell Topping Due to Undeclared Almonds (September 4) The only 7.25-ounce bottles of Hershey's Chocolate Shell Topping affected have the code 69N printed on the back of the bottle below the UPC symbol. The UPC/Bar Code is 346000. The item in question was available for purchase nationwide after July 8, 2008. Lucky Country Inc. Recalls All Natural Black Licorice Products (September 5) Lucky Country Inc. of Lincolnton, NC is recalling all of its natural black licorice products from California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Minnesota, New Hampshire, Pennsylvania, Utah, Virginia, and Washington State due to elevated levels of lead. Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16) Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product. FDA Updates Health Information Advisory on Melamine Contamination The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. Fresh from the Deli American Sub Sandwich Recalled by Landshire, Inc. Because of Possible Health Risk (August 28) Landshire, Inc. is recalling its American Sub sandwich because it has 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. Allergy Alert on Undeclared Dairy in Margaritaville Island Lime Tortilla Chips (September 12) El Matador Enterprises, makers of Margaritaville Tortilla Chips is voluntarily recalling 13-ounce bags of Margaritaville Island Lime Tortilla Chips because they may contain undeclared whey in the spice blend. FDA warns of instant coffee in U.S. from China - MSNBC FDA warns of instant coffee in U.S. from China - MSNBC
WASHINGTON - U.S. regulators warned the public on Friday not to consume seven Mr. Brown instant coffee and milk tea products that were made in China because of concerns they may be contaminated with melamine. The Food and Drug Administration said the Source: www.msnbc.msn.com FDA Faulted for Lack of Produce Oversight - Washington Post FRIDAY, Sept. 26 (HealthDay News) -- As food-safety problems continue to rock the United States, resulting in massive recalls, illness and even death, the federal Food and Drug Administration remains underfunded and understaffed to protect consumers Source: www.washingtonpost.com FDA faulted for produce oversight - Reuters WASHINGTON (Reuters) - Preparations for a biological attack and repeated outbreaks of food poisoning have interfered with efforts by the U.S. Food and Drug Administration to improve the safety of fresh produce, according to a report released on Source: www.reuters.com Eli Lilly Hit With Another FDA Delay - Street.Com Eli Lilly ( LLY Quote - Cramer on LLY - Stock Picks ) said late Friday that investors will have to wait longer still to find out whether blood thinner prasugrel wins regulatory approval in the U.S. The company and partner Daiichi Sankyo revealed Source: www.thestreet.com Indevus shares double deals with FDA, Teva - Boston Globe NEW YORK— Shares of Indevus Pharmaceuticals Inc. more than doubled Friday after the company said it is collaborating with Teva Pharmaceutical Industries Ltd. to develop a treatment for stuttering and could move forward with its delayed horomonal Source: www.boston.com FDA reviews experimental use of anemia drugs - Boston Globe WASHINGTON— Federal health regulators said Friday they are reviewing an experimental use of blockbuster anemia drugs made by Amgen and Johnson & Johnson that has been associated with higher death rates in a study involving stroke patients. Earlier Source: www.boston.com Report: FDA lax in oversight of produce industry - San Diego Union-Tribune FRESNO – The Food and Drug Administration's efforts to combat food-borne illness are hampered by staffing shortages, infrequent inspections and lax enforcement at fresh produce processing plants, according to congressional investigators. The Source: www.signonsandiego.com FDA warns of instant coffee in U.S. from China - MSNBC FDA warns of instant coffee in U.S. from China - MSNBC
WASHINGTON - U.S. regulators warned the public on Friday not to consume seven Mr. Brown instant coffee and milk tea products that were made in China because of concerns they may be contaminated with melamine. The Food and Drug Administration said the Source: www.msnbc.msn.com FDA Warns About Instant Coffee Made in China - ABC News Milk products collected from a market are seen at a government food safety laboratory in Wuhan in Milk products collected from a market are seen at a government food safety laboratory in Wuhan in central China's Hubei province Tuesday, Sept. 23 Source: www.abcnews.go.com Report: FDA lax in oversight of produce industry - San Diego Union-Tribune FRESNO – The Food and Drug Administration's efforts to combat food-borne illness are hampered by staffing shortages, infrequent inspections and lax enforcement at fresh produce processing plants, according to congressional investigators. The Source: www.signonsandiego.com RPT-UPDATE 2-US FDA probing deaths in J&J anemia drug study - Reuters WASHINGTON, Sept 26 (Reuters) - U.S. health officials said on Friday they were reviewing a higher rate of deaths among patients treated with a Johnson & Johnson (JNJ.N: Quote , Profile , Research , Stock Buzz ) anemia drug in a German study of stroke Source: www.reuters.com Our drugs are safe and effective: Ranbaxy - Business Standard Our drugs are safe and effective: Ranbaxy - Business Standard
"Ranbaxy is confident that all its pharmaceutical products are safe and effective, including the HIV/AIDs drugs it supplies to Africa through various aid programmes, including PEPFAR," the company said in a statement. The company was reacting to US Source: www.business-standard.com Canadian prescription drug supplier ending Hub program - Boston Globe Four years after Mayor Thomas M. Menino bucked federal regulators and made Boston the biggest city nationally to offer low-cost Canadian prescription drugs to employees and retirees, the program has fizzled, never having attracted more than a few Source: www.boston.com Food Safety Report Vexing - Tampa Bay Online FRESNO, Calif. - The Food and Drug Administration's efforts to combat food-borne illness are hampered by infrequent inspections, not enough staff and the failure to implement a program devoted to the safety of fresh produce, according to Source: www2.tbo.com Federal report says too few inspections, staff hamper FDA efforts to - Chicago Tribune FRESNO, Calif. (AP) _ The Food and Drug Administration's efforts to combat food-borne illness are hampered by infrequent inspections, not enough staff and the failure to implement a program devoted to the safety of fresh produce, according to Source: www.chicagotribune.com September 25, 2008FDA Issues Health Information Advisory on Infant Formula FDA Issues Health Information Advisory on Infant Formula
In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Drug Shortage: Fentanyl transdermal patch Availability information updated. FDA Clears Test to Help Doctors Manage Heart Transplant Patients The U.S. Food and Drug Administration announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Web site for additional information on this current drug shortage Ralston Foods Issues Allergy Alert For Undeclared Milk Ingredients In Western Family Variety Pack Instant Oatmeal (September 15) Ralston Foods, Division of Ralcorp Holdings, Inc. is recalling 14664 cartons of Western Family Variety Pack Instant Oatmeal cereal bearing the "Best If Used By" Date Code of "DEC0409N" (found on the box top) because a small number of cartons contain an undeclared milk ingredient. FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications. FDA Approves Treatment for Rare Neurologic Disease The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms. CaJohns Fiery Foods Company Recalls HDH Grillin' Sauce (September 24) CaJohns Fiery Foods Company is recalling a total of 103 individual bottles of HDH Grillin' Sauce sold between the dates of 01/01/07 and 09/15/08. This recall is initiated due to the possibility of non-declared contents on the Ingredient Declaration. The products contain the listed Worcestershire Sauce, but may not be parenthetically listed as to it's ingredients one of which is Anchovies, a serious allergen to specific individuals. These products also contain the listed Soy Sauce, but may not be parenthetically listed as to it's ingredients. Soy Sauce contains Soybeans and Wheat which are serious allergens to specific individuals. Syneron wins FDA clearance for Matrix RF ablative applicator - Pharmaceutical Business Review Syneron wins FDA clearance for Matrix RF ablative applicator - Pharmaceutical Business Review
The FDA clearance follows Syneron's receipt in Europe of CE mark clearance for the Matrix RF. Matrix RF utilizes Syneron's radio frequency technology to provide effective ablation and resurfacing through fractional tissue heating at three ablation Source: www.pharmaceutical-business-review.com Report: FDA oversight of produce is too lax - MSNBC FRESNO, Calif. - A federal report says the Food and Drug Administration's efforts to combat food-borne illness are hampered by factors including not enough staff. The Government Accountability Office says in the draft report obtained Thursday by The Source: www.msnbc.msn.com Traceability dominates FFVA food safety seminar - Thepacker.com Traceability dominates FFVA food safety seminar - Thepacker.com
David Acheson, Food and Drug Administration assistant commissioner for food protection, discusses how government agencies handled the Salmonella Saintpaul outbreak that implicated tomatoes during a Sept. 23 food safety session at the Florida Fruit Source: thepacker.com Some HDH-brand grilling sauce is recalled - The Money Times Washington -- The U.S. Food and Drug Administration announced the recall of 103 bottles of HDH-brand grilling sauce because of a labeling error. The FDA said CaJohns Fiery Foods Co. of Columbus, Ohio, initiated the recall because the product might Source: www.themoneytimes.com AARP Rx Watchdog Report Finds Specialty Drug Prices Soar - Phramalive.com WASHINGTON, September 25, 2008 -According to a report released today by AARP, drug manufacturers have substantially raised prices on the 144 specialty drugs most commonly used by people in Medicare Part D. The latest AARP Rx Watchdog Report, from Source: www.pharmalive.com Chinese Milk Products Banned in South Korea - Eflux Media South Korea on Thursday banned the import of Chinese milk and milk powder products, blamed for causing kidney damage to thousands of Chinese babies. Also two snacks found to contain the chemical melamine were recalled. The Korea Food and Drug Source: www.efluxmedia.com China Milk Ban Spreads as WHO Denounces Contamination (Update1) - Bloomberg Sept. 25 (Bloomberg) -- India, South Korea and France banned Chinese dairy products as the World Health Organization said the chemical contamination that has killed four infants and sickened 53,000 in China is ``deplorable.'' India, Asia's third Source: www.bloomberg.com FDA charges Surprise store over claims of cancer cure - AZCentral.com FDA charges Surprise store over claims of cancer cure - AZCentral.com
The Federal Trade Commission has charged a Surprise-area business with using deceptive advertising to sell bogus cancer cures. Mary Spohn and her company, Herbs for Cancer, could be forced to pay thousands of dollars in restitution if found guilty by Source: www.azcentral.com K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18) K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18)
K-FAT INC. of 13 Meadow St., Brooklyn, NY 11206, is recalling its 150g packages of MUT GUNG SWEETENED GINGER because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious life-threatening allergic reactions if they consume this product. FDA Issues Draft Guidance on Regulating Genetically Engineered Animals The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals. Recall of Patak's Dopiaza Cooking Sauce (September 4) ACH Food Companies, Inc. is recalling its Patak's Dopiaza Cooking Sauce sold in the United States because it may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk may run the risk of serious or life-threatening allergic reaction if they consume these products. The product is distributed nationally through retail stores. ACH Food Companies is notifying its distributors and stores that carry this product that it contains an undeclared milk allergen and to immediately remove it from distribution. Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16) Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product. FDA Warns Consumers Not to Eat Certain Mussel Products from Bantry Bay Seafood (August 15) The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. FDA Proposes Label Requirements for Refused Imported Foods The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk. FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications. FDA Issues Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Ralston Foods Issues Allergy Alert For Undeclared Milk Ingredients In Western Family Variety Pack Instant Oatmeal (September 15) Ralston Foods, Division of Ralcorp Holdings, Inc. is recalling 14664 cartons of Western Family Variety Pack Instant Oatmeal cereal bearing the "Best If Used By" Date Code of "DEC0409N" (found on the box top) because a small number of cartons contain an undeclared milk ingredient. FDA Approves DNA Test to Measure Hepatitis B Virus Levels The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections. Sepracor sees FDA filing by late 2008, early 2009 - Boston Globe Sepracor sees FDA filing by late 2008, early 2009 - Boston Globe
MARLBOROUGH, Mass.— Sepracor Inc. said Wednesday it expects to ask the Food and Drug Administration for approval of an epilepsy drug candidate by the end of 2008 or early 2009. The drug is licensed from Portugal-based Bial. Sepracor said it is Source: www.boston.com FDA: Report milk from China - Guam Pacific Daily News The U.S. Food and Drug Administration issued an updated advisory yesterday that melamine-tainted infant formula from China might have ended up in U.S. stores that serve Asian communities. Melamine is a chemical widely used in plastics, adhesives Source: www.guampdn.com FDA Issues Draft Guidance on Regulating Genetically Engineered Animals FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals. Recalls and Safety Alerts: Preventing Meningitis in Children with Cochlear Implants (December 2007) This story originally aired in December 2007. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is reminding healthcare practitioners about the importan... FDA Drug Safety Newsletter FDA Drug Safety Newsletter
Summer 2008 edition available for healthcare professionals and the medical community. Phosphocol P 32 (Chromic Phosphate P 32 Suspension) Risk of leukemia associated with off-label intra-articular use in children. Peppers Unlimited, Inc. Recalls La Torre Jalapeno Nacho Slices (August 14) Peppers Unlimited, Inc. of Fontana California is voluntarily recalling 580 cases of La Torre Jalapeno Nacho Slices because of possible product contamination caused by a chemical reaction between the product and the can potentially resulting in a swollen and/or ruptured container and significant off flavor. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. Interior Alaska Fish Processors, Inc. Recalls Santa's Smokehouse Brand Smoked Keta Salmon (August 13) The recalled product was sold in random weight portions and packaged in clear plastic vacuum sealed bags with the Santa's Smokehouse "teriyaki style smoked keta salmon" label on it. The only batch subject to the recall will be labeled with the batch number '637', found on the Santa's Smokehouse label. Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16) Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product. Infant Formula Manufactured in China Contaminated With Melamine UPDATE - FDA investigation of Asian markets found no Chinese-manufactured infant formula on shelves. LifePak CR Plus Automated External Defibrillators Class I Recall because the shock button is not visible, making the responder unable to provide shock therapy. Tarceva (erlotinib) Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. September 24, 2008Warnings on Raw Jalapeño and Serrano Peppers from Mexico Warnings on Raw Jalapeño and Serrano Peppers from Mexico
Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Bottled Water Everywhere: Keeping it Safe Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe. FDA Approves Treatment for Rare Neurologic Disease The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms. FDA warns Covidien about plant problems - Reuters FDA warns Covidien about plant problems - Reuters
WASHINGTON (Reuters) - U.S. regulators have warned health-care products maker Covidien Ltd about manufacturing problems at a plant in Missouri, a letter released on Tuesday said. The Food and Drug Administration in an August 12 letter said inspectors Source: www.reuters.com Ranbaxy AIDS Drug Won't Be Funded by U.S. After FDA Inspection - Bloomberg Sept. 25 (Bloomberg) -- AIDS drugs made by Ranbaxy Laboratories Ltd. won't be purchased under an American program to supply medicines to developing countries after the U.S. cited the company for violations in two of its plants. The President's Source: www.bloomberg.com Sepracor sees FDA filing by late 2008, early 2009 - Boston Globe MARLBOROUGH, Mass.— Sepracor Inc. said Wednesday it expects to ask the Food and Drug Administration for approval of an epilepsy drug candidate by the end of 2008 or early 2009. The drug is licensed from Portugal-based Bial. Sepracor said it is Source: www.boston.com US FDA warns Covidien about plant problems - Forbes WASHINGTON (Reuters) - U.S. regulators have warned health-care products maker Covidien Ltd about manufacturing problems at a plant in Missouri, a letter released Tuesday said. The Food and Drug Administration in an Aug. 12 letter said inspectors Source: www.forbes.com I-Flow Gets 510(k) Approval From FDA for Oxygenated Topical Dressing - RTT News (RTTNews) - Wednesday, provider of low-cost drug delivery systems and surgical products I-Flow Corporation (IFLO: News ), through its wholly owned subsidiary AcryMed Inc., announced that it has received 510(k) clearance from the US Food and Drug Source: www.rttnews.com FDA cracks down on unapproved drugs - Philadelphia Inquirer WASHINGTON - Federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks. The eye wash, known as Source: www.philly.com FDA Approves Treatment for Rare Neurologic Disease FDA Approves Treatment for Rare Neurologic Disease
The U.S. Food and Drug Administration today announced that it has approved an immune globulin product called Gamunex for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder characterized by progressive weakness and impaired sensory function in the legs and arms. FDA to Post Quarterly Report of Potential Safety Issues The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS). FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection See Web site for additional information on this current drug shortage FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined. In-Body Pediatric Devices Pose Unique Challenges Implantable pediatric medical devices are exciting examples of cutting-edge medical technology. But they require special considerations on the part of parents, health professionals, and scientists who design devices. FDA Issues Draft Guidance on Regulating Genetically Engineered Animals The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals. Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated See additional information in Related Information section. FDA Proposes Label Requirements for Refused Imported Foods FDA Proposes Label Requirements for Refused Imported Foods
The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk. Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process. FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case
The U.S. Food and Drug Administration announced today that a West Virginia cattle dealer has been sentenced to six months probation for refusing to obey court orders in 2006 and 2008 that prohibited her from introducing animals into the food supply until the FDA had approved her record-keeping system. The FDA initiated the case after illegal levels of drug residue were found repeatedly in calves that Shirley A. Rhodes of Sandyville sold for use as human food. FDA Approves DNA Test to Measure Hepatitis B Virus Levels The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections. Mom's Food Products, Inc. Issues Allergy Alert On Undeclared Eggs in Sandwiches and Potato Salad (September 23) Mom's Food Products, Inc. of Ft Worth, TX is recalling all Tuna Salad sandwiches, Pimento Cheese sandwiches, and potato salad because they may contain eggs in the salad dressing. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. Peppers Unlimited, Inc. Recalls La Torre Jalapeno Nacho Slices (August 14) Peppers Unlimited, Inc. of Fontana California is voluntarily recalling 580 cases of La Torre Jalapeno Nacho Slices because of possible product contamination caused by a chemical reaction between the product and the can potentially resulting in a swollen and/or ruptured container and significant off flavor. FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses. Warning on Certain Mussel Products from Bantry Bay Seafood FDA is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods because they may be contaminated with azaspiracid toxins. Bimbo Bakeries USA Issues an Allergy Alert on Undeclared Tree Nuts in Oroweat 100 Percent Whole Wheat Bread Packaging (September 16) Bimbo Bakeries USA today announced a voluntary recall of Oroweat 100 Percent Whole Wheat bread because it may contain tree nuts that are not listed on the label. Individuals with allergies to tree nuts run the risk of a serious and or life threatening reaction if they consume this product. FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. Allergy Alert on Undeclared Dairy in Margaritaville Island Lime Tortilla Chips (September 12) El Matador Enterprises, makers of Margaritaville Tortilla Chips is voluntarily recalling 13-ounce bags of Margaritaville Island Lime Tortilla Chips because they may contain undeclared whey in the spice blend. Energy Drinks Should Have Caffeine Warning Labels, Study Says - Bloomberg Energy Drinks Should Have Caffeine Warning Labels, Study Says - Bloomberg
Sept. 24 (Bloomberg) -- Energy drinks can have 10 times or more caffeine as soft drinks, prompting Johns Hopkins University scientists to recommend the drinks carry labels with caffeine content and warnings about the health risks. Energy drinks are Source: www.bloomberg.com ImmuneRegen Scientist to Present Viprovex(R) Pre-Clinical Study - MSN MoneyCentral ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), will present pre-clinical study results that indicate that its drug candidate Viprovex® enhances the safety and efficacy of Tamiflu Source: news.moneycentral.msn.com OSI warns of deaths after taking cancer drug - Newsday OSI Pharmaceuticals of Melville and its partner, California -based Genentech Inc. , warned doctors yesterday that two patients had died of liver damage after taking the cancer drug Tarceva. OSI has marketed Tarceva - used to treat lung and pancreatic Source: www.newsday.com Showing entries for Category: dog-food-recall - San Francisco Examiner Mars Petcare, manufacturer of Pedigree and several other kinds of dog and cat food, has issued a recall because of possible salmonella contamination. Find out if your brand is one of them by clicking on the logos here . UPC codes can also be checked Source: www.examiner.com Anthera Completes Special Protocol Assessment With FDA and Receives - Biloxi Sun Herald SAN MATEO, Calif., Sept. 24 -- Anthera Pharmaceuticals announced today they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA's Special Source: www.sunherald.com FDA targets 2 eye products - Chicago Tribune The federal government told companies to stop selling certain unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects had been associated with the products. The Food and Drug Source: www.chicagotribune.com What's going on: 2nd Whole Foods opens in Ann Arbor - Detroit Free Press A second Whole Foods Market in Ann Arbor opens today. A bread-breaking ceremony and grand opening will be at 9 a.m. at the store, 990 W. Eisenhower Pwy. in the Cranbrook Village shopping center. The first 500 customers each day through Sunday will Source: www.freep.com Dyax Announces Completion of Biologics License Application for DX-88 - Forbes Dyax Corp. (NASDAQ:DYAX) announced today the completion of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of Dyax's lead product candidate DX-88 (ecallantide) for the treatment of hereditary Source: www.forbes.com Stem cell debate: Cures, jobs and ethics - Detroit Free Press Ryan Dinkgrave lived a carefree life in Livonia until he was diagnosed with type I diabetes at age 10. Suddenly everything was ordered and careful. "It makes you rethink everything you do," he said. "You're young, you're told you need to do shots Source: www.freep.com 40 Tons of Chinese Food Products Rejected Since 2006 - Digital Chosunilbo 40 Tons of Chinese Food Products Rejected Since 2006 - Digital Chosunilbo
Korea's food safety authority has recalled or discarded more than 40 tons of food products imported from China since 2006. According to a report by the Korea Food and Drug Administration a carcinogenic material called cyclamate along with other Source: english.chosun.com FDA request holds up Athersys obesity drug - Cleveland Plain Dealer Blog The U.S. Food and Drug Administration has requested more information about future clinical trials of the obesity drug being developed by Cleveland biopharmaceutical company Athersys Inc. While the FDA's request puts study of the drug, called ATHX-105 Source: blog.cleveland.com Teva and Kowa Announce Strategic Partnership to Create a Leading - MSN MoneyCentral Teva Pharmaceutical Industries Ltd. TEVA and Kowa Company, Ltd. today announced that they have signed a definitive agreement to establish a leading generic pharmaceutical company in Japan. The company, Teva-Kowa Pharma Co., Ltd. will seek to leverage Source: news.moneycentral.msn.com FDA targets 2 eye products - Chicago Tribune The federal government told companies to stop selling certain unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects had been associated with the products. The Food and Drug Source: www.chicagotribune.com Boehringer, Pfizer Lung Drug Adds Heart Risk in Study (Update1) - Bloomberg Sept. 23 (Bloomberg) -- Boehringer Ingelheim GmbH and Pfizer Inc. 's Spiriva, one of the most commonly prescribed drugs for emphysema and chronic bronchitis, may increase the risk of fatal heart complications and stroke, a study found. Patients with Source: www.bloomberg.com Teva asthma drug approved for children 4 to 11 - CNN Money NEW YORK (Associated Press) - Teva Pharmaceutical Industries Ltd. said Tuesday the Food and Drug Administration approved its ProAir asthma medication for patients as young as 4 years old. The albuterol sulfate inhaler, which is used to open up a Source: money.cnn.com Study warns inhalers may carry health risks - Houston Chronicle CHICAGO — Inhaler drugs used by millions of people with emphysema and bronchitis may slightly raise the risk for heart attacks and even death, a study suggests. The results aren't conclusive and inhalers provide significant relief for these Source: www.chron.com What's going on: 2nd Whole Foods opens in Ann Arbor - Detroit Free Press A second Whole Foods Market in Ann Arbor opens today. A bread-breaking ceremony and grand opening will be at 9 a.m. at the store, 990 W. Eisenhower Pwy. in the Cranbrook Village shopping center. The first 500 customers each day through Sunday will Source: www.freep.com FDA cracks down on unapproved eye wash, skin cream - Los Angeles Times WASHINGTON -- Federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks. The eye wash, known as Source: www.latimes.com September 23, 2008FDA Meeting Provides Green Light for Cell Therapeutics Submission of - Forbes FDA Meeting Provides Green Light for Cell Therapeutics Submission of - Forbes
SEATTLE, Sept. 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTICD and MTA: CTIC) announced today that following a meeting with the U.S. Food and Drug Administration (FDA) data from the First-line Indolent Trial (FIT) would be Source: www.forbes.com US Court Denies Teva's Motion for Summary Judgment in PULMICORT - MSN MoneyCentral WILMINGTON, Del. , Sept. 23 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the US District Court for the District of New Jersey has denied Teva's Motion for Summary Judgment of no infringement in the PULMICORT RESPULES(R) (budesonide Source: news.moneycentral.msn.com Nation/World briefs - Detroit News WASHINGTON -- Defense Secretary Robert Gates said Tuesday the Pentagon may be able to send thousands more combat troops to Afghanistan starting next spring, but he also pointedly cautioned against overdoing a military buildup in a country offended by Source: www.detnews.com Mylan Receives FDA Approval for Generic Version of Parkinson's - MSN MoneyCentral PITTSBURGH , Sept. 22 /PRNewswire-FirstCall/ -- Mylan Inc. MYL today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Source: news.moneycentral.msn.com FDA cracks down on unapproved drugs - WIS-TV WASHINGTON (AP) - The Food and Drug Administration is cracking down on an unapproved skin cream and eye wash. The agency is threatening to seize the products and take legal action against the companies marketing them without government approval. The Source: www.wistv.com FDA tells companies to halt sales of 2 unapproved drugs - Boston Globe WASHINGTON - The Food and Drug Administration told companies to stop selling two unapproved drugs used to irrigate eyes during surgery and to treat lesions such as diabetic ulcers, saying dangerous side effects were associated with the products. The Source: www.boston.com Teva asthma drug approved for children 4 to 11 - CNBC Teva asthma drug approved for children 4 to 11 - CNBC
NEW YORK - Teva Pharmaceutical Industries Ltd. said Tuesday the Food and Drug Administration approved its ProAir asthma medication for patients as young as 4 years old. The albuterol sulfate inhaler, which is used to open up a person's lungs during Source: www.cnbc.com Athersys Announces Update On ATHX-105 Development Plans and Results of - MSN MoneyCentral CLEVELAND, Sept. 23, 2008 (GLOBE NEWSWIRE) -- Athersys, Inc. (Nasdaq:ATHX) today announced that the U.S. Food and Drug Administration (FDA) has requested additional information relating to the Company's Investigational New Drug (IND) application for Source: news.moneycentral.msn.com FDA Cracks Down on Skin Cream and Eye Wash - Kait 8 WASHINGTON (AP) - The Food and Drug Administration is cracking down on an unapproved skin cream and eye wash. The agency is threatening to seize the products and take legal action against the companies marketing them without government approval. The Source: www.kait8.com Sanofi-Aventis gets child approval on allergy drug - Boston Globe NEW YORK— Sanofi-Aventis said Monday the Food and Drug Administration approved its allergy treatment Nasacort for children between 2 and 5 years old. The drug, which is a nasal spray, treats perennial allergic rhinitis, or year-round allergies Source: www.boston.com Takeda Submits a New Drug Application in the U.S. for Alogliptin (SYR - Market Wire OSAKA, JAPAN--(Marketwire - September 23, 2008) - Takeda Pharmaceutical Company Limited (Takeda) announced today that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), submitted a New Drug Application (NDA) to the Source: www.marketwire.com Boehringer, Pfizer Lung Drug Adds Heart Risk in Study (Update1) - Bloomberg Sept. 23 (Bloomberg) -- Boehringer Ingelheim GmbH and Pfizer Inc. 's Spiriva, one of the most commonly prescribed drugs for emphysema and chronic bronchitis, may increase the risk of fatal heart complications and stroke, a study found. Patients with Source: www.bloomberg.com China's milk scandal bares government shortcomings - Guardian Unlimited BEIJING (AP) - The note posted in July on the Web site of China's food safety inspection agency came from a doctor: There had been a sudden rise in infants turning up at his hospital with kidney stones after drinking the same brand of formula. The Source: www.guardian.co.uk China’s milk scandal bares government failures - MSNBC BEIJING - The note posted in July on the Web site of China’s food safety inspection agency came from a doctor: There had been a sudden rise in infants turning up at his hospital with kidney stones after drinking the same brand of formula. The Source: www.msnbc.msn.com Ingen Technologies Receives FDA Export Certification for China - MSN MoneyCentral Ingen Technologies Receives FDA Export Certification for China - MSN MoneyCentral
YUCAIPA, Calif., Sept. 23, 2008 (GLOBE NEWSWIRE) -- Ingen Technologies, Inc. (Pink Sheets:ITEC), an emerging medical device manufacturer within the $4-Billion respiratory device market, announced today that the Food & Drug Administration has provided Source: news.moneycentral.msn.com US FDA warns Covidien about plant problems - Forbes WASHINGTON (Reuters) - U.S. regulators have warned health-care products maker Covidien Ltd about manufacturing problems at a plant in Missouri, a letter released Tuesday said. The Food and Drug Administration in an Aug. 12 letter said inspectors Source: www.forbes.com FDA cracks down on eye wash and skin cream - Boston Globe WASHINGTON— Federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks. The eye wash, known as Source: www.boston.com FDA orders two unapproved drugs off the market - Reuters WASHINGTON (Reuters) - U.S. health officials warned companies on Tuesday to stop selling unapproved versions of an eye-surgery solution and a prescription wound cream that have been linked to serious health problems. The products are ophthalmic Source: www.reuters.com Syneron(TM) Receives FDA Clearance for Versatile Matrix RF(TM - MSN MoneyCentral Syneron(TM) Medical Ltd. (NASDAQ: ELOS), an innovator in the development, marketing and sales of elos(TM) combined-energy medical aesthetic devices, today received FDA clearance for the Matrix RF(TM) applicator for use in dermatological procedures Source: news.moneycentral.msn.com Genzyme expects FDA ruling on Myozyme - Boston Globe Genzyme Corp ., a Cambridge biotechnology company, said today that it expects to know by Nov. 29 if regulators approve or reject its plans to increase production of the drug Myozyme. In October, a Food and Drug Administration panel will discuss Source: www.boston.com UPDATE 1-Genzyme sees US FDA action on Myozyme by late Nov - Reuters NEW YORK, Sept 23 (Reuters) - Genzyme Corp (GENZ.O: Quote , Profile , Research , Stock Buzz ) said on Tuesday it expected U.S. regulators to make a decision on whether to approve larger-scale production of its Pompe disease treatment, Myozyme, by Nov Source: www.reuters.com UPDATE 1-US FDA warns Covidien about plant problems - Forbes WASHINGTON, Sept 23 (Reuters) - U.S. regulators have warned health-care products maker Covidien Ltd about manufacturing problems at a plant in Missouri, a letter released on Tuesday said. The Food and Drug Administration in an Aug. 12 letter said Source: www.forbes.com Asia on alert over tainted milk - News.com.au Asia on alert over tainted milk - News.com.au
COUNTRIES from Indonesia to Japan have announced strict checks and banned sales of Chinese dairy products to contain an escalating scandal over melamine-tainted milk. The crisis, which has made nearly 53,000 children ill in China and killed four, has Source: www.news.com.au UNC Charlotte to Evaluate Potential Adjuvant Activity of ImmuneRegen's - MSN MoneyCentral ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), today announces a collaborative relationship with the University of North Carolina at Charlotte to evaluate ImmuneRegen's Viprovex as a possible Source: news.moneycentral.msn.com Quinine eases leg cramps but might have other side effects - San Diego Union-Tribune Leg cramps are especially jarring at night, when they can literally mean a rude awakening. They can strike suddenly, and they tend to become more common with age. A popular remedy is quinine, which produces the bitter flavor in tonic water. But there Source: www.signonsandiego.com Firms that follow rules deserve protection - Chicago Sun-Times It's a heart-rending story -- a botched medical procedure costs a musician her right arm, the one with which she strummed her guitar. As you might expect, this case landed in court, and the clinic responsible for this horrific error settled. But that Source: www.suntimes.com New test for breast tumors - Detroit Free Press You're lying face down on a massage table, your breast encased in a water bath through an opening in the table. Tiny ports from a surrounding ring fire ultrasound waves. There are no X-rays. There is no pain. There is no holding still for 20 minutes Source: www.freep.com Infant Formula Manufactured in China Infant Formula Manufactured in China
FDA issues Health Information Advisory due to reports of contamination with melamine. Recalls and Safety Alerts: Severe Pain with Osteoporosis Drugs (March 2008) This story originally aired in March 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. FDA is alerting healthcare professionals that severe bone, join... In-Body Pediatric Devices Pose Unique Challenges Implantable pediatric medical devices are exciting examples of cutting-edge medical technology. But they require special considerations on the part of parents, health professionals, and scientists who design devices. 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. FDA Law Enforcers Crack Down on Illegal Botox Scammer FDA's Office of Criminal Investigations found physicians who put profit before patients when they injected them with fake Botox Cosmetic. FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. September 22, 2008Ranbaxy may lose $140 mn on US ban - MSN India Ranbaxy may lose $140 mn on US ban - MSN India
Mumbai: Ranbaxy Laboratories, India’s biggest drug maker, may lose as much as $140 million of revenue in 2009 after the US drug regulator blocked sale of more than 30 generic medicines and 7 APIs made in two factories of the company, according to Source: news.in.msn.com FDA says plastics with BPA are safe - Island Packet Online WASHINGTON -- With scientists at odds over the safety of a chemical found in plastic baby bottles, metal cans and other food packaging, consumers got minimal guidance Sept. 16 about how to protect themselves. At a scientific hearing, the Food and Source: www.islandpacket.com Coapt Systems Launches FDA Cleared Novielle Voice (TM) for Restoration - Forbes PALO ALTO, Calif., Sept. 21 /PRNewswire/ -- Coapt Systems Inc. today announced the launch of its Novielle Voice family of injectable fillers at the 112th annual meeting of the American Academy of Otolaryngology -- Head and Neck Surgery (AAO-HNS) in Source: www.forbes.com Most prescription drugs kids take not approved for their use - Detroit Free Press If you didn't know that, you've got company. The majority of parents surveyed in a recent poll think whatever their pediatrician prescribes is safe. But according to doctors and researchers at the University of Michigan, 70% of available drugs Source: www.freep.com FDA to review genetically engineered animals - MSNBC WASHINGTON - Super Chicken strutted a step closer to the dinner table Thursday. The government said it will start considering proposals to sell genetically engineered animals as food, a move that could lead to faster-growing fish, cattle that can Source: nbcsports.msnbc.com Mylan Receives FDA Approval for Generic Version of Parkinson's - MSN MoneyCentral PITTSBURGH , Sept. 22 /PRNewswire-FirstCall/ -- Mylan Inc. MYL today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Source: news.moneycentral.msn.com A diet pill for dogs? - San Francisco Gate A diet pill for dogs? - San Francisco Gate
Last January, when Pfizer launched Slentrol , the first (and currently only) FDA-approved "doggie diet" medication, I was incredulous. Was a diet pill really being touted as the magic bullet for man's overweight best friends? Slentrol, which is Source: www.sfgate.com FDA Gives In to Food Torturers - Austin Chronicle I'm not talking about farmers, food artisans, or local food enterprises – but about the corporate giants of agribusiness that insist on torturing nature's delicious, nutritional edibles for their own fun and profit. They take food into their labs Source: www.austinchronicle.com FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined. FDA Updates Health Information Advisory on Melamine Contamination On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula or source materials from China. FDA Issues Draft Guidance on Regulating Genetically Engineered Animals The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals. Voluntary Recall: Wegmans In-Store Made Bagels (September 10) Wegmans Food Markets, Inc. is voluntarily recalling all varieties of its in-store made bagels and bialys (flattened bagels with various toppings, i.e. pizza) sold in the bakery and purchased between August 24 and September 9, 2008. This recall is being initiated because the bagels may contain pieces of a metal spring from a mixer that entered the dough, which is produced at Wegmans' Central Bakeshop in Rochester, posing a possible choking hazard. FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding. News - Politics and Law - CNET News News - Politics and Law - CNET News
Federal authorities are ramping up an investigation of a 20-year-old college student for allegedly hacking into Alaska Gov. Sarah Palin's e-mail account. Sarah Palin (Credit: Alaska governor's office) The FBI searched the apartment of alleged hacker Source: news.cnet.com Mylan Receives FDA Approval for Generic Version of Parkinson's - MSN MoneyCentral PITTSBURGH , Sept. 22 /PRNewswire-FirstCall/ -- Mylan Inc. MYL today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Source: news.moneycentral.msn.com Pets and Pet Supplies - Newsday BEIJING (AP) _ The head of China's food safety watchdog resigned Monday in the wake of the tainted baby formula scandal that has sickened nearly 53,000 infants, state media reported. The official Xinhua News Agency said Li Changjiang stepped down Source: www.newsday.com Chief of China's top quality-control agency steps down - International Herald Tribune SHANGHAI : The head of China's top quality-control agency resigned Monday in the wake of a growing scandal over the country's tainted milk supply, the state-run Xinhua news agency reported. The toxic milk has sickened more than 50,000 infants and has Source: www.iht.com Phase Forward Lincoln Safety Group to Host Nationwide Drug Safety - Earthtimes WALTHAM, Mass. - (Business Wire) Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced that its Lincoln Safety Group will host a series of free seminars on “ The Evolving Source: www.earthtimes.org Angiotech announces reorganization and cost reduction initiatives - Forbes Date to be established for Annual General Meeting Shareholder vote to be postponed regarding proposed transaction with Ares Management and New Leaf Venture Partners VANCOUVER, Sept. 22 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc Source: www.forbes.com Labopharm Submits New Drug Application to FDA for DDS-04A to Treat - Earthtimes LAVAL, QC , Sept. 22 - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has submitted a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act to the U.S. Food and Drug Administration (FDA) for Source: www.earthtimes.org Alpharma to Develop and Commercialize DURECT's ELADUR(TM) Pain Patch - MSN MoneyCentral CUPERTINO, Calif. , Sept. 22 /PRNewswire-FirstCall/ -- DURECT Corporation DRRX announced today that it has entered into a development and license agreement with an affiliate of Alpharma Inc. ALO granting such party the exclusive worldwide rights to Source: news.moneycentral.msn.com Protalix BioTherapeutics Provides Enrollment Update for the Phase III - MSN MoneyCentral Protalix BioTherapeutics, Inc. PLX , today announced that the Company anticipates completion, during the second half of 2008, of enrollment in its on-going pivotal phase III clinical trial of prGCD, a proprietary plant cell expressed recombinant form Source: news.moneycentral.msn.com Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
See Web site for additional information on this current drug shortage FDA 101: Dietary Supplements Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers. Disposable Battery Operated Lavage System (BOLS) The cutting of battery pack cables for disposal can lead to sparks, fires, toxic fumes, and explosions. August 2008 Safety-Related Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. 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 LifePak CR Plus Automated External Defibrillators UPDATE - Recall classified as Class I. FDA Law Enforcers Crack Down on Illegal Botox Scammer FDA's Office of Criminal Investigations found physicians who put profit before patients when they injected them with fake Botox Cosmetic. Warnings on Raw Jalapeño and Serrano Peppers from Mexico Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. If this bill seeks compassion, why aren’t treatments free? - Kansas City Star If this bill seeks compassion, why aren’t treatments free? - Kansas City Star
A bill introduced by Sen. Sam Brownback of Kansas — S. 3046 — attempts to address an important need related to cancer and other illnesses and frustratingly slow drug approvals by the Food and Drug Administration. Its title even begins with Source: www.kansascity.com Living Food: We trust it's safe? - Seattle Post Intelligencer In the face of nearly zero demand from consumers, genetically engineered food is on its way. Don't worry about any shock at seeing re-engineered fish or meat: The government doesn't want you to know what you're eating. That fits a pattern of denying Source: seattlepi.nwsource.com Cell Therapeutics plans to submit Supplemental Filing for Zevalin - RTT News (RTTNews) - Monday, Cell Therapeutics, Inc. (CTICD: News ) said, following a meeting with the U.S. Food and Drug Administration, or FDA, that the data from the First-line Indolent Trial, or FIT, would be sufficient to support a submission for a Source: www.rttnews.com China Milk Scandal Spreads; Hong Kong Girl Sickened (Update2) - Bloomberg Sept. 21 (Bloomberg) -- Hong Kong authorities said a girl in the city developed a kidney stone after drinking Chinese milk containing the industrial chemical melamine, the first known illness outside mainland China linked to a spate of contaminations Source: www.bloomberg.com Cell Therapeutics to submit Supplemental Filing for Zevalin Label - RTT News (RTTNews) - Biopharmaceutical company Cell Therapeutics, Inc. (CTICD: News ) said Monday that subsequent to a meeting with the U.S. Food and Drug Administration, or FDA, the data from the First-line Indolent Trial, or FIT, would be sufficient to Source: www.rttnews.com Drug problem - Press & Sun-Bulletin Editor's Note -- Pharmaceutical waste is contaminating the nation's drinking water supplies, and American consumers are not being given much guidance on how to dispose of unwanted medicines, an Associated Press investigation finds. Second of a two Source: www.pressconnects.com Safe packaging - Guardian Unlimited We were disappointed that your article about the health effects of bisphenol A (Packaging chemical linked to greater risk of diseases, September 17) claimed the chemical is found in plastic bottles. This is not borne out by the facts. If you had Source: www.guardian.co.uk September 21, 2008FDA warns consumers not to buy milk products from China on the - Newsday FDA warns consumers not to buy milk products from China on the - Newsday
WASHINGTON (AP) _ Although no trace of infant formula from China has turned up in this country, U.S. authorities said Friday they are taking added precautions to keep out tainted milk products. The Food and Drug Administration has widened its Source: www.newsday.com Boston Sci looking to future of new stents - Minneapolis Star Tribune Boston Sci looking to future of new stents - Minneapolis Star Tribune
Boston Scientific Corporation's mantra has long been "Delivering What's Next." But for the past two years, the medical technology company's big division in Maple Grove has been thwarted from launching potentially lucrative heart devices as a result Source: www.startribune.com WHO to warn customers over Sandoz drugs - Financial Times Sandoz, the generic drugs arm of Novartis of Switzerland, risks losing World Health Organisation authorisation to sell some of its antibiotics after regulators identified manufacturing problems at one of its South African factories. Officials are Source: www.ft.com More consolidation seen in generic drug industry - BusinessWeek A wave of consolidation that has reshaped the generic drug industry in recent years will continue, experts say, as companies like Teva Pharmaceutical Industries and Mylan Inc. compete for new business in emerging global markets. This year already has Source: www.businessweek.com Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution
See Web site for additional information on this current drug shortage FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications. FDA Issues Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Phosphocol P 32 (Chromic Phosphate P 32 Suspension) Risk of leukemia associated with off-label intra-articular use in children. FDA Approves First Drug for Treatment of Chorea in Huntington's Disease The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington's disease. Chorea is the jerky, involuntary movement that occurs in people with this disease. Infant Formula Manufactured in China FDA issues Health Information Advisory due to reports of contamination with melamine. Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. |
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