September 20, 2008Farmers back GM animals study - West Online Farmers back GM animals study - West Online
Australian farmers have urged authorities to consider the use of genetically modified animals for meat, milk and fish after US authorities this week unveiled guidelines to regulate the controversial technology. The US Food and Drug Administration has Source: www.thewest.com.au US bans key Indian drug imports - BBC South-Asia The United States Food and Drug Administration (FDA) says it has banned the import of more than 30 generic drugs made by Indian drug firm Ranbaxy. The FDA said the decision was made after it found manufacturing quality problems at two of Ranbaxy's Source: news.bbc.co.uk FDA issues rules for gene modified animals - Newsday The Food and Drug Administration opened the way yesterday for a bevy of genetically engineered salmon, cows and other animals to leap from the laboratory to the marketplace, unveiling an approval process that would treat the modified creatures like Source: www.newsday.com Scarless Surgery Uses Body's Own Openings - Washington Post At Northwestern Memorial Hospital, a procedure known as natural orifice transluminal endoscopic surgery, or NOTES, was used to remove Albert Pagliuca's gallbladder. Some doctors question whether the risks of this type of surgery outweigh the benefits Source: www.washingtonpost.com J&J Touts Psoriasis-Drug Data - Wall Street Journal Johnson & Johnson said its experimental drug ustekinumab was more effective at treating the skin disease psoriasis than Amgen Inc.'s blockbuster drug Enbrel in a J&J-funded patient study. J&J, of New Brunswick, N.J., already has applied for Food and Source: online.wsj.com FDA Plans Rules for Modified Food Animals - Wall Street Journal WASHINGTON -- The Food and Drug Administration released proposed guidelines on how to regulate genetically engineered animals, in a move that is expected to pave the way for them to enter the food supply. The biotech industry has long sought to use Source: online.wsj.com Altered animals could become food - Detroit Free Press The Food and Drug Administration issued a proposed legal framework for how it would resolve such questions as whether the altered animals are safe for human consumption and pose no serious environmental risks. Source: www.freep.com Drug Label, Maimed Patient and Test for Court - New York Times MARSHFIELD, Vt. — When Diana Levine starts talking about her rock ’n’ roll days, she plays a little air guitar, mimicking the way she used to handle her electric bass in bands like the Re-Bops and Duke and the Detours. But Ms. Levine is missing Source: www.nytimes.com Now, Ranbaxy AIDS drug under US lens - Business Standard A United States Congressional committee has widened the scope of its ongoing inquiry into the United States Food and Drug Administration's (USFDA) handling of drug- marketing approvals of India's leading drug-maker Ranbaxy. Source: www.business-standard.com Drug Shortage: Fentanyl transdermal patch Drug Shortage: Fentanyl transdermal patch
Availability information updated. 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. 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. Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection See Web site for additional information on this current drug shortage 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. FDA to Review Genetically Engineered Farm Animals - ABC News FDA to Review Genetically Engineered Farm Animals - ABC News
FDA officials said they are focusing on animals that will be used as food, or to produce medications that would then be consumed by people or other animals. (Getty Images ) Super Chicken strutted a step closer to the dinner table Thursday. The Source: www.abcnews.go.com FDA Proposes Regulations for Genetically Engineered Animals - Forbes THURSDAY, Sept. 18 (HealthDay News) -- The prospect of foods and other products from so-called genetically engineered animals moved a step closer to reality Thursday, as U.S. regulators said producers of such animals will have to prove they are safe Source: www.forbes.com FDA issues rules for genetically modified animals - Reuters WASHINGTON (Reuters) - Animals genetically engineered to produce drugs and healthier foods will be subjected to review to help protect consumers from any unknown risks, the U.S. Food and Drug Administration said on Thursday. The FDA published Source: www.reuters.com Covidien's Phosphocol may up leukemia risk-US FDA - Reuters WASHINGTON, Sept 18 (Reuters) - Covidien Ltd (COV.N: Quote , Profile , Research , Stock Buzz ) has warned doctors that its Phosphocol P 32 product may increase the risk for leukemia in certain situations, the U.S. Food and Drug Administration said on Source: www.reuters.com Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008) Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008)
This story originally aired in April 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. The Institute for Safe Medication Practices (ISMP) recently des... Potential Problems at Two Baltimore Pharmacies FDA is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. FDA to review genetically engineered animals - MSNBC 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: www.msnbc.msn.com FDA Considers Engineered Animals For Food - CBS News Two featherless chickens peck around in some grass at the Hebrew University in Rehovot. Israeli scientists at the Agriculture department of the university have genetically engineered bare-skinned chickens as part of a research project to develop Source: www.cbsnews.com FDA Takes First Step in Approving Genetically Engineered Meat - Redorbit.com The U.S. Food and Drug Administration on Thursday released a set of proposed guidelines that producers of genetically engineered animals would need to follow to determine any possible risks to humans. The latest step increases the possibility of Source: www.redorbit.com FDA issues rules for genetically modified animals - Reuters WASHINGTON (Reuters) - Animals genetically engineered to produce drugs and healthier foods will be subjected to review to help protect consumers from any unknown risks, the U.S. Food and Drug Administration said on Thursday. The FDA published Source: www.reuters.com FDA to review genetically engineered farm animals - San Diego Union-Tribune 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 resist mad cow disease, or perhaps heart-healthier eggs laid by a new breed of Source: www.signonsandiego.com Indian Pharma Ranbaxy Slammed by FDA - BusinessWeek Drug companies hoping to outsource production to low-cost locations in India are probably following closely the news about Ranbaxy Laboratories, arguably India’s premier drugmaker and a big seller of generic drugs in the U.S. and other markets. A Source: www.businessweek.com China's product safety agency orders milk tainted with chemical off - Los Angeles Times SHIJIAZHUANG, China (AP) _ China's national product safety agency said all batches of milk that have tested positive for an industrial chemical are being recalled and by Saturday the dairy sections of many stores were empty in Beijing and Shanghai Source: www.latimes.com FDA Takes Steps To Ensure Tainted Milk Is Kept Out - CBS 2 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: wcbstv.com FDA eyes mandatory tracking program for food - MSNBC WASHINGTON - A mandatory traceability system in the United States would help improve the safety of food, such as produce, a health official told lawmakers on Wednesday, three weeks after the government declared an end to the worst foodborne outbreak Source: nbcsports.msnbc.com Are You Storing Food Safely? 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. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage Preventing Medical Errors: Preventing Patient Deaths from Fentanyl Patches (September 2007) This story originally aired in September 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. A recent report from the Institute for Safe Medication Prac... Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
See Web site for additional information on this current drug shortage FDA Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. 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. 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. September 19, 2008FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection - Forbes FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection - Forbes
GE Healthcare, a unit of General Electric Company (NYSE:GE), today announced that the Food and Drug Administration (FDA) has approved AdreView(TM) (Iobenguane I 123 Injection), a molecular imaging agent for the detection of rare neuroendocrine tumors Source: www.forbes.com The free market's not always the fair and honest market - Los Angeles Times Market forces are great. Until they're not. After nearly three decades of conservatives insisting that government has no business meddling in the private sector, the Bush administration on Friday announced a sweeping plan to spend hundreds of Source: www.latimes.com Glaxo says US still reviewing clot disorder drug - Reuters WASHINGTON, Sept 19 (Reuters) - U.S. health officials still are reviewing GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research , Stock Buzz ) proposed clotting disorder drug Promacta, the company said on Friday. The London-based drugmaker said it Source: www.reuters.com Osteoporosis, osteopenia screening and prevention are best done when - Los Angeles Times JUST A few years back, it was heresy to suggest that, when it comes to protecting bones, early treatment may not be the answer. Part of the rite of passage through menopause a decade ago became bone-density screening. Around age 50, many women would Source: www.latimes.com UPDATE 1-Glaxo says US still reviewing clot disorder drug - Reuters WASHINGTON, Sept 19 (Reuters) - U.S. health officials still are reviewing GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research , Stock Buzz ) proposed clotting disorder drug Promacta, the company said on Friday. The London-based drugmaker said it Source: www.reuters.com US steps up inspections to keep out tainted milk - Seattle Post Intelligencer WASHINGTON -- 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 inspections Source: seattlepi.nwsource.com Roche receives FDA complete response letter for arthritis drug - Pharmaceutical Business Review Roche receives FDA complete response letter for arthritis drug - Pharmaceutical Business Review
According to the company, the FDA has not requested any new clinical studies surrounding the efficacy or safety of Actemra as a prerequisite for approval. The FDA has requested additional documentation related to the manufacturing of Actemra and Source: www.pharmaceutical-business-review.com GE Healthcare says FDA approves imaging agent - Forbes General Electric Co. said Friday that regulators have approved its imaging agent AdreView to aid in the detection of rare neuroendocrine tumors. GE Healthcare said the injectable agent will help doctors detect tumors including neuroblastoma, a cancer Source: www.forbes.com FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection - Forbes GE Healthcare, a unit of General Electric Company (NYSE:GE), today announced that the Food and Drug Administration (FDA) has approved AdreView(TM) (Iobenguane I 123 Injection), a molecular imaging agent for the detection of rare neuroendocrine tumors Source: www.forbes.com UPDATE 1-Glaxo says US still reviewing clot disorder drug - Reuters WASHINGTON, Sept 19 (Reuters) - U.S. health officials still are reviewing GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research , Stock Buzz ) proposed clotting disorder drug Promacta, the company said on Friday. The London-based drugmaker said it Source: www.reuters.com FDA issues rules for genetically modified animals - HealthCentral.com WASHINGTON (Reuters) - Animals genetically engineered to produce drugs and healthier foods will be subjected to review to help protect consumers from any unknown risks, the U.S. Food and Drug Administration said on Thursday. The FDA published Source: www.healthcentral.com 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 Asthma and acetaminophen, No safe tan, and Food tracking - WTVH Asthma and acetaminophen, No safe tan, and Food tracking - WTVH
The Food and Drug Administration works to set up a food tracking group to prevent more food sicknesses and more easily track their source. The Food and Drug Administration is looking at a mandatory tracking program to improve the safety of food in Source: www.wtvh.com UPDATE 1-Glaxo says US still reviewing clot disorder drug - Reuters WASHINGTON, Sept 19 (Reuters) - U.S. health officials still are reviewing GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research , Stock Buzz ) proposed clotting disorder drug Promacta, the company said on Friday. The London-based drugmaker said it Source: www.reuters.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 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 China's food safety scandal now includes liquid milk, Singapore bans - Minneapolis Star Tribune I'm so done with this global economy. If we're going to send food back and forth around the world, then we need tighter controls in place. … read more We need to know what they are doing (our inspectors) at the site where it is grown, where it is Source: www.startribune.com Glaxo says US still reviewing clot disorder drug - Reuters WASHINGTON, Sept 19 (Reuters) - U.S. health officials still are reviewing GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research , Stock Buzz ) proposed clotting disorder drug Promacta, the company said on Friday. The London-based drugmaker said it Source: www.reuters.com Meat—from lab to plate? - Chicago Tribune The Food and Drug Administration on Thursday opened the way for genetically engineered salmon, cows and other animals to move from the laboratory to the marketplace, unveiling an approval process that would treat the modified creatures like drugs Source: www.chicagotribune.com Chocoholics sour on new Hershey’s formula - MSNBC Chocoholics sour on new Hershey’s formula - MSNBC
Apparently not in some Hershey’s products that contained milk chocolate for years, and that has passionate chocolate aficionados fighting mad. Products such as Whatchamacallit, Milk Duds, Mr. Goodbar and Krackel no longer have milk chocolate Source: www.msnbc.msn.com FTC, FDA Warn Consumers about Bogus Cancer Therapies - Eflux Media Five companies which marketed false cancer cures have been sued by the Federal Trade Commission. The agency is asking that they stop marketing products for which there is “no credible evidence” that they “can prevent, cure, or treat cancer of Source: www.efluxmedia.com FDA proposes approval process for genetically modified animals - Los Angeles Times The Food and Drug Administration on Thursday opened the way for a bevy of genetically engineered salmon, cows and other animals to leap from the laboratory to the marketplace, unveiling an approval process that would treat the modified creatures like Source: www.latimes.com FDA to review genetically engineered farm animals - San Diego Union-Tribune 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 resist mad cow disease, or perhaps heart-healthier eggs laid by a new breed of Source: www.signonsandiego.com FDA issues rules for genetically modified animals - Environmental News Network WASHINGTON (Reuters) - Genetically engineered animals moved closer to the dinner table on Thursday as the U.S. Food and Drug Administration made the process it will use to review new proposals public. The FDA published proposed detailed guidelines Source: www.enn.com FDA Tells Gilead to Take 1 More Step - Motley Fool Gilead Sciences (Nasdaq: GILD ) got bad news from the Food and Drug Administration this week when it learned that its inhaled antibiotic treatment to help with cystic fibrosis-related infections wouldn't be approved. In rejecting Gilead's aztreonam Source: www.fool.com APPLIED NANOSCIENCE TO ASSIST EMERGENCY FILTRATION PRODUCTS IN - Forbes APPLIED NANOSCIENCE TO ASSIST EMERGENCY FILTRATION PRODUCTS IN - Forbes
APPLIED NANOSCIENCE TO ASSIST EMERGENCY FILTRATION PRODUCTS IN RESPONSE TO FDA COMMENTS Ryan Vlastelica rv COPYRIGHT Copyright Thomson Financial News Limited 2007. Source: www.forbes.com Ranbaxy hires Giuliani after FDA bans drugs - Financial Times Ranbaxy, India's largest drugmaker, has enlisted the support of Rudy Giuliani, the former New York mayor, to help it address concerns raised by US regulatory authorities about the manufacture of its drugs. Hiring the high-profile Republican Source: www.ft.com FDA issues rules for genetically modified animals - Environmental News Network WASHINGTON (Reuters) - Genetically engineered animals moved closer to the dinner table on Thursday as the U.S. Food and Drug Administration made the process it will use to review new proposals public. The FDA published proposed detailed guidelines Source: www.enn.com FTC, FDA Warn Consumers about Bogus Cancer Therapies - Eflux Media Five companies which marketed false cancer cures have been sued by the Federal Trade Commission. The agency is asking that they stop marketing products for which there is “no credible evidence” that they “can prevent, cure, or treat cancer of Source: www.efluxmedia.com Ranbaxy Calls Rudy Giuliani for Help - BusinessWeek We’ve been covering the ongoing problems that Indian drugmaker Ranbaxy has been having with the FDA in the U.S. Now, just days after the FDA announced a ban on the import of over two dozen of its drugs, Ranbaxy has unveiled its latest tactic: The Source: www.businessweek.com FDA proposes approval process for genetically modified animals - Los Angeles Times The Food and Drug Administration on Thursday opened the way for a bevy of genetically engineered salmon, cows and other animals to leap from the laboratory to the marketplace, unveiling an approval process that would treat the modified creatures like Source: www.latimes.com Altered animals could become food - Detroit Free Press Altered animals could become food - Detroit Free Press
The Food and Drug Administration issued a proposed legal framework for how it would resolve such questions as whether the altered animals are safe for human consumption and pose no serious environmental risks. Source: www.freep.com How it will work - Minneapolis Star Tribune The Food and Drug Administration will start considering proposals to sell genetically engineered animals as food, or to produce medications using such animals that would then be consumed by people or by other animals. The regulations will entail a Source: www.startribune.com Gene-altered food in sight - Detroit News 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: www.detnews.com September 18, 2008FDA Clears Test to Help Doctors Manage Heart Transplant Patients 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. 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. 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). Drug Shortage: Fentanyl transdermal patch Availability information updated. Preventing Medical Errors: What to Do about Unretrieved Device Fragments (January 2008) This story originally aired in January 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. A recent FDA article in the journal Nursing2007 alerts health... Preventing Medical Errors: More Patient Deaths from Luer Misconnections (October 2007) This story originally aired in October 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. A recent FDA article in the publication "Safe Practices in Pa... FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States. 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. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. Infant Formula Manufactured in China Infant Formula Manufactured in China
FDA issues Health Information Advisory due to reports of contamination with melamine. LifePak CR Plus Automated External Defibrillators Class I Recall because the shock button is not visible, making the responder unable to provide shock therapy. Disposable Battery Operated Lavage System (BOLS) The cutting of battery pack cables for disposal can lead to sparks, fires, toxic fumes, and explosions. LifePak CR Plus Automated External Defibrillators UPDATE - Recall classified as Class I. 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... Preventing Medical Errors: Preventing Patient Deaths from Fentanyl Patches (September 2007) This story originally aired in September 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. A recent report from the Institute for Safe Medication Prac... Preventing Medical Errors: What to Do about Unretrieved Device Fragments (January 2008) This story originally aired in January 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. A recent FDA article in the journal Nursing2007 alerts health... Safety and Food Packaging FDA monitors all packaging that comes into contact with food. Here's an overview of how FDA conducts safety reviews of food contact substances. 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 Warns Consumers About Potential Problems at Two Baltimore Pharmacies The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment. FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts 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. Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. FDA defends plastic linked with health risks - NWITimes.com FDA defends plastic linked with health risks - NWITimes.com
WASHINGTON - With scientists at odds about the risks of a chemical found in plastic baby bottles, metal cans and other food packaging, the government on Tuesday gave consumers some tips on how to reduce their exposure to BPA even as it said the Source: nwitimes.com FDA steps up Cipro warnings - Courier-Journal After the anthrax attacks of 2001 Cipro became a household word when it was identified as a drug that could fight that deadly bacteria. Recently, Cipro was in the spotlight again as federal regulators imposed their most urgent safety warning on Cipro Source: www.courier-journal.com Indian Pharma Ranbaxy Slammed by FDA - BusinessWeek Drug companies hoping to outsource production to low-cost locations in India are probably following closely the news about Ranbaxy Laboratories, arguably India’s premier drugmaker and a big seller of generic drugs in the U.S. and other markets. A Source: www.businessweek.com Ranbaxy disappointed with FDA action - Times of India NEW DELHI: Wednesday's action by the FDA is the second instance in less than three years of it issuing a warning to Ranbaxy, while it is also under a separate criminal probe by the US Justice Department for allegedly bringing adulterated and Source: timesofindia.indiatimes.com FDA To Rule On Bioengineered Animals - Free Internet Press The U.S. Food and Drug Administration (FDA) will release Thursday long-awaited regulatory guidelines governing genetic engineering of animals for food, drugs or medical devices. Although none of the provisions is likely to surprise the biotech Source: freeinternetpress.com FDA eyes mandatory tracking program for food - MSNBC WASHINGTON - A mandatory traceability system in the United States would help improve the safety of food, such as produce, a health official told lawmakers on Wednesday, three weeks after the government declared an end to the worst foodborne outbreak Source: www.msnbc.msn.com U.S. lawmaker questions FDA, cites industry ties - Reuters UK WASHINGTON (Reuters) - The U.S. Food and Drug Administration appears to be giving priority to projects that benefit the pharmaceutical industry rather than helping consumers, a top Democratic lawmaker said on Wednesday. The head of the U.S. House of Source: uk.reuters.com September 17, 2008FDA: Baby bottle plastic safe, reduce exposure - Detroit Free Press FDA: Baby bottle plastic safe, reduce exposure - Detroit Free Press
At a scientific hearing, the Food and Drug Administration defended its assessment that bisphenol A -- or BPA -- is safe, even as the first major study of health effects in people linked it with possible risks for heart disease and diabetes. Source: www.freep.com J&J reports anemia drug linked to deaths in study - International Herald Tribune TRENTON, New Jersey : A blockbuster anemia drug made by a Johnson & Johnson company has been linked to the deaths of some patients in an experiment testing whether it could help stroke patients. J&J's Ortho Biotech unit said late Wednesday that it Source: www.iht.com Ovation Pharma buys Huntington’s disease drug - Crain's Chicago Business (Crain’s) — Ovation Pharmaceuticals Inc. said Wednesday it has acquired the rights to a medication that treats the nervous system disorder Huntington’s disease, a move the Deerfield firm called one of its largest deals. Privately held Ovation Source: www.chicagobusiness.com Health Winners & Losers: Gilead - Street.Com Health-care stocks generally suffered the same fate Wednesday as the broader stock market, trading deeply in the red. Gilead Sciences ( GILD Quote - Cramer on GILD - Stock Picks ) sank on news the Food and Drug Administration refused to approve the Source: www.thestreet.com Ranbaxy Laboratories, Ltd., Retains Former New York City Mayor - MSN MoneyCentral PRINCETON, N.J. , Sept. 17 /PRNewswire/ -- Ranbaxy Laboratories Ltd., today announced that they have retained the services of former New York City Mayor Rudy Giuliani and Giuliani Partners to provide advice and review compliance issues related to the Source: news.moneycentral.msn.com Ranbaxy Shaken By FDA Action - Forbes Ranbaxy Laboratories responded with shock Wednesday to the U.S. Food and Drug Administration's actions to limit the importation of its drugs into the U.S. "Ranbaxy is very disappointed in the action FDA has taken. The company has responded to each Source: www.forbes.com U.S. lawmaker questions FDA, cites industry ties - Reuters WASHINGTON, Sept 17 (Reuters) - The U.S. Food and Drug Administration appears to be giving priority to projects that benefit the pharmaceutical industry rather than helping consumers, a top Democratic lawmaker said on Wednesday. The head of the U.S Source: www.reuters.com FDA: Baby bottle plastic safe, reduce exposure - Detroit Free Press 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 Tuesday about how to protect themselves. At a scientific hearing, the Food and Drug Source: www.freep.com Ranbaxy gets bitter pills from Uncle Sam - Hindustan Times The US Food and Drug Administration (FDA) has banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories, citing serious manufacturing deficiencies at two of the company’s plants in India. The banned drugs include Zocor, a Source: www.hindustantimes.com Indian Pharma Ranbaxy Slammed by FDA - BusinessWeek Drug companies hoping to outsource production to low-cost locations in India are probably following closely the news about Ranbaxy Laboratories, arguably India’s premier drugmaker and a big seller of generic drugs in the U.S. and other markets. A Source: www.businessweek.com U.S. lawmaker questions FDA, cites industry ties - Reuters U.S. lawmaker questions FDA, cites industry ties - Reuters
WASHINGTON, Sept 17 (Reuters) - The U.S. Food and Drug Administration appears to be giving priority to projects that benefit the pharmaceutical industry rather than helping consumers, a top Democratic lawmaker said on Wednesday. The head of the U.S Source: www.reuters.com FDA: Baby bottle plastic safe, reduce exposure - Detroit Free Press 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 Tuesday about how to protect themselves. At a scientific hearing, the Food and Drug Source: www.freep.com FDA Tests Gilead's Patience - Forbes Gilead Sciences had a minor setback this week, but it's nothing that the company can't handle, analysts said. The Foster City, Calif.-based pharmaceutical company said it received a letter from the U.S. Food and Drug Administration asking for more Source: www.forbes.com Mylan Jumps on Ranbaxy's Warning for Generic Drugs (Update2) - Bloomberg Sept. 17 (Bloomberg) -- Mylan Inc ., the biggest U.S. maker of generic drugs, rose in New York trading after an analyst said the company could benefit from the regulatory woes of Ranbaxy Laboratories Ltd. Mylan, based in Canonsburg, Pennsylvania Source: www.bloomberg.com Ranbaxy disappointed with FDA action - Times of India NEW DELHI: Wednesday's action by the FDA is the second instance in less than three years of it issuing a warning to Ranbaxy, while it is also under a separate criminal probe by the US Justice Department for allegedly bringing adulterated and Source: timesofindia.indiatimes.com FDA to allow irradiation of spinach and lettuce - Chicago Tribune The controversial practice of irradiating food to kill microorganisms such as E. coli and salmonella can now be used on spinach and lettuce. The Food and Drug Administration has previously approved irradiation on beef, eggs, poultry, oysters and Source: www.chicagotribune.com Home Made Brand Foods Recalls Tuna Salad Because of Possible Health Risk (August 11) Home Made Brand Foods Recalls Tuna Salad Because of Possible Health Risk (August 11)
Home Made Brand Foods is voluntarily recalling approximately 4890 pounds of Ready-to-Eat Tuna Salad with an expiration date of 8/19/08. This product 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. S and M (USA) Enterprise Corp. Issues Alert on Undeclared Sulfites in Grove Grow Notes Brand Dried Bamboo Fungus Veiled Lady (August 12) The recall was initiated after routine sampling by New York State Department of Agriculture and Markets food inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in Grove Grow Notes brand Dried Bamboo Fungus Veiled Lady which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reaction in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites Wegmans Expands Dates of Bagel Recall and Includes Additional Bakery Products (September 11) Wegmans Food Markets, Inc. has expanded the voluntary recall of in-store made bagels and bialys first announced on Wednesday, September 10. The recall is now expanded to include Challah bread and in-store baked bagels, bialys and rolls. These products were sold in Wegmans' bakery department between June 19 and September 11, 2008. September 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Tumor necrosis factor-α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) Opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers. 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. 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. Pacific Consolidated brand Mobile Oxygen Storage Tank Class I Recall because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing. Mars Petcare US Issues Voluntary Recall of Everson, PA Plant Dry Pet Food Product due to Potential Salmonella Contamination (September 12) Mars Petcare US announced a voluntary recall of products manufactured at its Everson, Pennsylvania facility. The pet food is being voluntarily recalled because of potential contamination with Salmonella serotypeSchwarzengrund. This voluntary recall only affects the United States. FDA to allow irradiation of spinach and lettuce - Chicago Tribune FDA to allow irradiation of spinach and lettuce - Chicago Tribune
The controversial practice of irradiating food to kill microorganisms such as E. coli and salmonella can now be used on spinach and lettuce. The Food and Drug Administration has previously approved irradiation on beef, eggs, poultry, oysters and Source: www.chicagotribune.com Indian Pharma Ranbaxy Slammed by FDA - BusinessWeek Drug companies hoping to outsource production to low-cost locations in India are probably following closely the news about Ranbaxy Laboratories, arguably India’s premier drugmaker and a big seller of generic drugs in the U.S. and other markets. A Source: www.businessweek.com FDA Tests Gilead's Patience - Forbes Gilead Sciences had a minor setback this week, but it's nothing that the company can't handle, analysts said. The Foster City, Calif.-based pharmaceutical company said it received a letter from the U.S. Food and Drug Administration asking for more Source: www.forbes.com Ranbaxy Shaken By FDA Action - Forbes Ranbaxy Laboratories responded with shock Wednesday to the U.S. Food and Drug Administration's actions to limit the importation of its drugs into the U.S. "Ranbaxy is very disappointed in the action FDA has taken. The company has responded to each Source: www.forbes.com Mylan shares rise as rival Ranbaxy gets FDA ban - BusinessWeek Shares of drug developer Mylan Inc. jumped Wednesday following the Food and Drug Administration's move to ban imports from the company's generic competitor Ranbaxy Laboratories. Pittsburgh-based Mylan's stock picked up 71 cents, or 6.6 percent, to Source: www.businessweek.com FDA: India's Generic Drug Giant Imports Blocked - Time (WASHINGTON) — The government closed U.S. borders Tuesday to more than 30 generic drugs — including popular antibiotics and cholesterol medicines — made by India's biggest pharmaceutical company, citing poor quality in two of its factories. The Source: www.time.com Gilead Cystic Fibrosis Drug Rejected by FDA - Street.Com Gilead Sciences ( GILD Quote - Cramer on GILD - Stock Picks ) said late Tuesday that U.S. regulators refused to approve the company's experimental cystic fibrosis drug. The Food and Drug Administration issued Gilead a complete response letter for Source: www.thestreet.com Ranbaxy vows to resolve U.S. import ban on generics - San Diego Union-Tribune MUMBAI, India – India's largest pharmaceutical company, Ranbaxy Laboratories, said Wednesday that it will resolve problems that led the U.S. Food and Drug Administration to ban the import of more than 30 of its generic drugs. On Tuesday, the FDA Source: www.signonsandiego.com FDA: Baby bottle plastic safe, reduce exposure - Detroit Free Press FDA: Baby bottle plastic safe, reduce exposure - Detroit Free Press
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 Tuesday about how to protect themselves. At a scientific hearing, the Food and Drug Source: www.freep.com Vivendy's Treatment for Morbus Morquio (MPS IVA) Granted Orphan Drug - Forbes Vivendy Therapeutics Ltd. today announced that its enzyme replacement therapy (ERT) for Mucopolysaccharidosis IVA, (MPS IVA-Morbus Morquio) has been granted Orphan Drug designation by the United States Food and Drug Administration (FDA). This Source: www.forbes.com FDA tries to keep some Indian drugs out of U.S. - Detroit Free Press The U.S. Food and Drug Administration is trying to stop imports of generic drugs from India's largest pharmaceutical company, which the agency says is not living up to clean manufacturing standards. The maker, Ranbaxy Laboratories Ltd., creates Source: www.freep.com Ranbaxy vows to resolve US import ban on generics - Washington Post MUMBAI, India -- India's largest pharmaceutical company, Ranbaxy Laboratories, said Wednesday that it will resolve problems that led the U.S. Food and Drug Administration to ban the import of more than 30 of its generic drugs. On Tuesday, the FDA Source: www.washingtonpost.com FDA cautious about chemical in plastic - Detroit News WASHINGTON -- With scientists at odds about the risks of a chemical found in plastic baby bottles, metal cans and other food packaging, the government Tuesday gave consumers some tips on how to reduce their exposure to BPA even as it said the Source: www.detnews.com Chemical is safe, FDA says, but . . . - Philadelphia Daily News WASHINGTON - With scientists at odds about the risks of a chemical found in plastic baby bottles, metal cans, and other food packaging, the government yesterday gave consumers some tips on how to reduce their exposure to BPA even as it called the Source: www.philly.com FDA Rejects Gilead Cystic Fibrosis Drug - Street.Com Gilead Sciences ( GILD Quote - Cramer on GILD - Stock Picks ) said late Tuesday that U.S. regulators refused to approve the company's experimental cystic fibrosis drug. The Food and Drug Administration issued Gilead a complete response letter for Source: www.thestreet.com FDA Bans Imports of 28 Indian-Made Drugs - Washington Post The Food and Drug Administration said yesterday that it was halting importation of 28 drugs made by the giant Indian generic drug maker Ranbaxy Laboratories because of manufacturing deficiencies at two of the company's plants. Douglas Throckmorton, a Source: www.washingtonpost.com FDA blocks generic-drug imports from India's Ranbaxy - Los Angeles Times WASHINGTON -- The government closed U.S. borders Tuesday to more than 30 generic drugs -- including popular antibiotics and cholesterol medicines -- made by India's biggest pharmaceutical company, citing poor quality in two of its factories. The Food Source: www.latimes.com US blocks generic drug imports from Ranbaxy - Times of India US blocks generic drug imports from Ranbaxy - Times of India
MIAMI: In a major setback to Indian pharmaceutical giant Ranbaxy, the US has blocked imports of generic drugs produced by it due to "serious" manufacturing deficiencies by two of its plants. "The Food and Drug Administration (FDA) has issued two Source: timesofindia.indiatimes.com US blocks drug import from Ranbaxy plants - Times of India MIAMI: In a major setback to Indian pharmaceutical giant Ranbaxy, the US has blocked imports of 30 generic drugs, including anti-biotics and cholesterol medicines, produced by it in two of its plants due to "serious" manufacturing deficiencies. "The Source: timesofindia.indiatimes.com FDA blocks generic-drug imports from India's Ranbaxy - Los Angeles Times WASHINGTON -- The government closed U.S. borders Tuesday to more than 30 generic drugs -- including popular antibiotics and cholesterol medicines -- made by India's biggest pharmaceutical company, citing poor quality in two of its factories. The Food Source: www.latimes.com FDA Rejects Gilead Cystic Fibrosis Drug - Street.Com Gilead Sciences ( GILD Quote - Cramer on GILD - Stock Picks ) said late Tuesday that U.S. regulators refused to approve the company's experimental cystic fibrosis drug. The Food and Drug Administration issued Gilead a complete response letter for Source: www.thestreet.com Today's Globe: osteoporosis trial, Indian generics, BPA debate, life - Boston Globe Amgen's experimental bone drug reduced the risk of spinal fractures in women with osteoporosis by 68 percent in a pivotal clinical trial, a robust result that raises the probability the drug can help restore the luster of the embattled biotechnology Source: www.boston.com Ranbaxy vows to resolve US import ban on generics - Washington Post MUMBAI, India -- India's largest pharmaceutical company, Ranbaxy Laboratories, said Wednesday that it will resolve problems that led the U.S. Food and Drug Administration to ban the import of more than 30 of its generic drugs. On Tuesday, the FDA Source: www.washingtonpost.com Vivendy's Treatment for Morbus Morquio (MPS IVA) Granted Orphan Drug - Forbes Vivendy Therapeutics Ltd. today announced that its enzyme replacement therapy (ERT) for Mucopolysaccharidosis IVA, (MPS IVA-Morbus Morquio) has been granted Orphan Drug designation by the United States Food and Drug Administration (FDA). This Source: www.forbes.com Ranbaxy vows to resolve US import ban on generics - Boston Globe MUMBAI, India— India's largest pharmaceutical company, Ranbaxy Laboratories, said Wednesday that it will resolve problems that led the U.S. Food and Drug Administration to ban the import of more than 30 of its generic drugs. On Tuesday, the FDA Source: www.boston.com US bans key Indian drug imports - BBC News The United States Food and Drug Administration (FDA) says it has banned the import of more than 30 generic drugs made by Indian drug firm Ranbaxy. The FDA said the decision was made after it found manufacturing quality problems at two of Ranbaxy's Source: www.bbc.co.uk India's Ranbaxy says "disappointed" over FDA move - Reuters India's Ranbaxy says "disappointed" over FDA move - Reuters
NEW DELHI, Sept 17 (Reuters) - Ranbaxy Laboratories (RANB.BO: Quote , Profile , Research , Stock Buzz ), India's top drug maker by sales, said on Wednesday it was disappointed by the U.S. Food and Drug Administration's move to ban dozens of its Source: www.reuters.com Indian shares fall 1 pct; Ranbaxy skids on drug ban - Reuters * ICICI extends fall on concerns of exposure to Lehman debt (Updates to mid- morning) MUMBAI, Sept 17 (Reuters) - Indian shares fell more than 1 percent on Wednesday morning, pulled down by ICICI Bank (ICBK.BO: Quote , Profile , Research , Stock Buzz Source: www.reuters.com US bans key Indian drug imports - BBC South-Asia The United States Food and Drug Administration (FDA) says it has banned the import of more than 30 generic drugs made by Indian drug firm Ranbaxy. The FDA said the decision was made after it found manufacturing quality problems at two of Ranbaxy's Source: news.bbc.co.uk September 16, 2008FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died. 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. Hop Lee Trading Co., Inc. Issues Alert on Undeclared Sulfites in Flower Brand Dried Sweet Potato (August 12) Hop Lee Trading Co. Inc. is recalling Flower brand Dried Sweet Potato because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product. 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... 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. 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. Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5) Sprouters Northwest, Inc. of Kent, Washington is recalling its alfalfa sprout products (alfalfa sprouts, onion sprouts, and salad sprouts) because they may be linked to a recent outbreak of Salmonellosis in Oregon and Washington State. To date, 13 cases of Salmonella Typhimirium infection have been associated with the consumption of raw alfalfa sprouts. 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 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. Voluntary Recall: Wegmans In-Store Made Bagels (September 10) 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 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 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. Disposable Battery Operated Lavage System (BOLS) The cutting of battery pack cables for disposal can lead to sparks, fires, toxic fumes, and explosions. HPV shot also protects against 2 other cancers - MSNBC HPV shot also protects against 2 other cancers - MSNBC
WASHINGTON - The Food and Drug Administration has updated the label of Merck's cervical cancer vaccine Gardasil, adding new information about its protective effects against two other gynecological cancers. The new labeling indicates the vaccine also Source: nbcsports.msnbc.com China vows better food safety after baby milk scandal - MSN Indonesia News China vowed Sunday to improve its food safety supervision after confirming 432 babies suffered kidney stones and at least one died after drinking contaminated milk powder. An efficient system should be set up to combine efforts of various ministries Source: news.id.msn.com Profits plunge 42% at Martha Stewart - Baltimore Sun NEW YORK - Martha Stewart Living Omnimedia Inc. reported a 42 percent drop in third-quarter earnings Thursday and warned that fourth-quarter earnings would fall far short of analysts' expectations, as a federal probe into a stock sale by its namesake Source: www.baltimoresun.com China recalls toxic baby food - Hindustan Times China has launched a nationwide probe into all domestic baby milk powder products, after samples of a major brand were found laced with a dangerous industrial chemical. Overnight, over 8000 tonnes of the Sanlu Group’s baby milk powder has been Source: www.hindustantimes.com Allergy Alert on Undeclared Dairy in Margaritaville Island Lime Tortilla Chips (September 12) 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 Approves 2008-2009 Flu Vaccines FDA Approves 2008-2009 Flu Vaccines
The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season. The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone. 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 Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. 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. September 15, 2008China vows better food safety - Independent Online China vows better food safety - Independent Online
Beijing - China vowed on Sunday to improve its food safety supervision after more than 400 babies fell ill from drinking contaminated milk powder, as a New Zealand company said it knew about the problem weeks ago. Health Minister Gao Qiang called for Source: www.iol.co.za Schering launches anesthesia-recovery drug - MSN MoneyCentral KENILWORTH, N.J. (AP) - Schering-Plough Corp. said Wednesday it has started selling its drug Bridion, which is designed to help reverse the effects of anesthesia, in Europe, and will begin selling the drug in other markets over the next few months Source: news.moneycentral.msn.com Today's Globe: how the brain sees, stem cell registry, FDA hires, drug - Boston Globe MIT scientists who tricked monkeys by swapping images of sailboats for teacups have figured out how the brain learns to recognize objects, a finding that could lead to robots that "see." Massachusetts has launched the International Stem Cell Registry Source: www.boston.com FDA hires 1,300 new doctors and scientists - NWITimes.com WASHINGTON - The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific Source: nwitimes.com Few safeguards for Mexican fruit and veggies bound for U.S.; producers - Baltimore Sun ALLENDE, Mexico (AP) _ At the end of a dirt road in northern Mexico, the conveyer belts processing hundreds of tons of vegetables a year for U.S. and Mexican markets are open to the elements, protected only by a corrugated metal roof. The U.S. Food Source: www.baltimoresun.com U.S. court vacates Teva exclusivity on Risperdal - Forbes JERUSALEM, Sept 14 (Reuters) - A U.S. appeals court has vacated a ruling made earlier in the year that gave Teva Pharmaceutical Industries 180 days of exclusivity to sell a generic version of anti-psychotic drug Risperdal, Teva said on Sunday Source: www.forbes.com HPV shot also protects against 2 other cancers - MSNBC WASHINGTON - The Food and Drug Administration has updated the label of Merck's cervical cancer vaccine Gardasil, adding new information about its protective effects against two other gynecological cancers. The new labeling indicates the vaccine also Source: nbcsports.msnbc.com ProStrakan Receives US FDA Approval for Sancuso - Phramalive.com ProStrakan Receives US FDA Approval for Sancuso - Phramalive.com
GALASHIELS, Scotland, 15 September, 2008 – ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company, today announces that it has received approval from the US Food and Drug Administration (FDA) for Sancuso®, ProStrakan Source: www.pharmalive.com Invitrogen, Biocare to Market FDA Approved Breast Cancer Test - MSN MoneyCentral Invitrogen Corporation, IVGN , a provider of essential life science technologies for research, production and diagnostics, has signed an exclusive U.S. distribution agreement with Biocare Medical LLC, a leading provider of immunohistochemistry Source: news.moneycentral.msn.com FDA Web Site on Drug Ads Developed by Drug Industry PR Firm - Center for Science in Public Interest WASHINGTON—Drug ads can be confusing and often deceptive, so it makes sense that the Food and Drug Administration would develop a web site aimed at helping consumers separate fact from fiction. But to develop such a site the FDA turned to a Source: www.cspinet.org FDA Expands Use of Cervical Cancer Vaccine - Time (WASHINGTON) — The cervical cancer vaccine Gardasil also works to prevent cancers of the vagina and vulva, federal health officials said Friday, as they approved expanding its use to protect against those diseases as well. The Food and Drug Source: www.time.com Hope, confusion in race for ovarian cancer tests - MSNBC WASHINGTON - Does a test that promises to find ovarian cancer sooner really do so? Could other tests nearing the market prolong survival by getting patients the right care faster? A race is on for blood tests to better detect this intractable killer Source: www.msnbc.msn.com Pfizer Safety Site Highlights Reporting of Drug Side Effects to FDA - Wall Street Journal It looks like Pfizer has followed Consumers Union’s advice in developing a new site about drug safety. In the upper right corner, the site has a link that directs users to the FDA’s MedWatch page for doing just that. It reminded us of a post we Source: blogs.wsj.com Bausch & Lomb says FDA approves Akreos lens - Forbes Eye care products maker Bausch & Lomb said Monday its Akreos implantable lens has received regulatory approval in the U.S., and it plans to begin shipping the product later this month. The Akreos Advanced Optics Aspheric Lens, which is designed to Source: www.forbes.com FDA accepts for review the Complete Response to ceftobiprole NDA - Phramalive.com BASEL, Switzerland, September 15, 2008 - Basilea Pharmaceutica Ltd. announces that the Food and Drug Administration (FDA) has accepted for review the Complete Response to the ceftobiprole New Drug Application (NDA) Approvable Letter. The Complete Source: www.pharmalive.com China vows better food safety after baby milk scandal - MSN Indonesia News China vows better food safety after baby milk scandal - MSN Indonesia News
China vowed Sunday to improve its food safety supervision after confirming 432 babies suffered kidney stones and at least one died after drinking contaminated milk powder. An efficient system should be set up to combine efforts of various ministries Source: news.id.msn.com Few safeguards for Mexican fruit and veggies bound for U.S.; producers - Baltimore Sun ALLENDE, Mexico (AP) _ At the end of a dirt road in northern Mexico, the conveyer belts processing hundreds of tons of vegetables a year for U.S. and Mexican markets are open to the elements, protected only by a corrugated metal roof. The U.S. Food Source: www.baltimoresun.com U.S. court vacates Teva exclusivity on Risperdal - Forbes JERUSALEM, Sept 14 (Reuters) - A U.S. appeals court has vacated a ruling made earlier in the year that gave Teva Pharmaceutical Industries 180 days of exclusivity to sell a generic version of anti-psychotic drug Risperdal, Teva said on Sunday Source: www.forbes.com Today's Globe: how the brain sees, stem cell registry, FDA hires, drug - Boston Globe MIT scientists who tricked monkeys by swapping images of sailboats for teacups have figured out how the brain learns to recognize objects, a finding that could lead to robots that "see." Massachusetts has launched the International Stem Cell Registry Source: www.boston.com FDA hires 1,300 new doctors and scientists - NWITimes.com WASHINGTON - The Food and Drug Administration said Thursday it has hired more than 1,300 professional staffers in a move that officials hope will help the beleaguered agency better protect the public health amid rapid technological and scientific Source: nwitimes.com HPV shot also protects against 2 other cancers - MSNBC WASHINGTON - The Food and Drug Administration has updated the label of Merck's cervical cancer vaccine Gardasil, adding new information about its protective effects against two other gynecological cancers. The new labeling indicates the vaccine also Source: nbcsports.msnbc.com China recalls toxic baby food - Hindustan Times China has launched a nationwide probe into all domestic baby milk powder products, after samples of a major brand were found laced with a dangerous industrial chemical. Overnight, over 8000 tonnes of the Sanlu Group’s baby milk powder has been Source: www.hindustantimes.com Schering launches anesthesia-recovery drug - MSN MoneyCentral KENILWORTH, N.J. (AP) - Schering-Plough Corp. said Wednesday it has started selling its drug Bridion, which is designed to help reverse the effects of anesthesia, in Europe, and will begin selling the drug in other markets over the next few months Source: news.moneycentral.msn.com China vows better food safety - Independent Online Beijing - China vowed on Sunday to improve its food safety supervision after more than 400 babies fell ill from drinking contaminated milk powder, as a New Zealand company said it knew about the problem weeks ago. Health Minister Gao Qiang called for Source: www.iol.co.za September 14, 2008FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts 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. Drug Shortages: Drugs to be Discontinued; Geref Diagnostic EMD Serono has made a business decision to discontinue this product. Infant Formula Manufactured in China FDA issues Health Information Advisory due to reports of contamination with melamine. 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. Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection See Web site for additional information on this current drug shortage Rituxan (rituximab) Progressive Multifocal Leukoencephalopathy with use of Rituxan in patient with rheumatoid arthritis. Drug Shortage: Fentanyl transdermal patch Availability information updated. Drug Shortages: Current Drug Shortages; Phospholine Iodide, Ophthalmic solution See Web site for additional information on this current drug shortage Drug Shortage: MVI Adult Injectable Hospira information updated. 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 |
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