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FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of Americas food supply since unveiling its Food Protection Plan in November 2007.
FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.
FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.
United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the Peoples Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety.
FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.
FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.
FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia.
FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.
Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release)
HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.
FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes.
FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A
Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles.
FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act.
FDA Announces New Labeling Changes for Regranex
The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.
FDA Announces Limited Return of Heartworm Drug to U.S. Market
ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs.
FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.
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Digitek Tablets Recalled
All lots of Digitek tablets distributed by Mylan Pharmaceuticals and sold under the labels "Bertek" or "UDL" are being recalled because they may contain a dangerous double dose of their active ingredient, digoxin.
Stronger Psychiatric Warning on Tamiflu
The flu drug Tamiflu now has a stronger warning about rare reports of delirium and abnormal behavior leading to self-injury, and, in some cases, death.
FDA Warns of Tysabri Liver Risk
The FDA says Tysabri, a drug that treats multiple sclerosis and Crohn's disease, is getting a new warning about possible liver risks.
FDA Warns of Allergy to Denture Cleansers
Use denture cleansers? The FDA wants to you to make sure you use those products as directed because of a possible risk of allergic reaction.
FDA Probes 4 Heparin Deaths
The FDA today announced that Baxter Healthcare has temporarily stopped making multiple-dose vials of the injectable blood-thinning drug heparin due to recent reports of four deaths and other serious reactions.
FDA Checks Reports of Botox Risks
The FDA says it's investigating reports of serious adverse events including death and respiratory failure linked with Botox, Botox Cosmetic, and Myobloc.
Suicide Warning for Antismoking Drug Chantix
Federal officials warn that the antismoking drug Chantix may be linked to suicides in some patients.
Birth Control Patch: Stronger Warning
The FDA has strengthened its warning on the risk of serious blood clots in women using the Ortho Evra birth control skin patch.
FDA: No Cold, Cough Medicines for Babies
WebMD brings baby cold medicine safety information from the FDA including which cough and cold medications are not safe for infant and children under 2.
FDA Eyes Anemia Drugs' Cancer Risk Again
The FDA is reviewing two more studies on cancer risks from ESA anemia drugs; the drug labels already bear a "black box" cancer warning.
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