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The Food and Drug Administration (or FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal) and radiation emitting devices (including non-medical devices), biologics, and blood products in the United States.
Organization and mandate
The FDA is divided into five major Centers: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Each center has its own origins and history, the oldest being CBER, which oversees blood products, vaccines, and newer therapeutics related to stem cells and gene therapy. CDER, which regulates human pharmaceuticals, receives considerable public scrutiny. Regulatory enforcement is carried out by Consumer Safety Officers within the Office of Regulatory Affairs and criminal matters are handled by special agents within the Office of Criminal Investigations (OCI)
Today, the FDA is headed by acting Commissioner, Dr. Andrew von Eschenbach, who succeeds Dr. Lester Crawford who resigned on September 23, 2005 only two months after his final Senate confirmation and a stormy tenure as deputy commissioner and acting commissioner, prior to his confirmation.
More on [ Food and Drug Administration ]
Center for Devices and Radiological Health
Center for Drug Evaluation and Research
Center for Veterinary Medicine
National Center for Toxicological Research
FDA Approves Multaq to Treat Heart Rhythm Disorder
Thu, 02 Jul 2009 14:39:00 -0000
The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.
FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban
Wed, 01 Jul 2009 16:17:00 -0000
The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.
FDA Seeks Public Input on Tobacco Regulation
Tue, 30 Jun 2009 16:37:00 -0000
The U.S. Food and Drug Administration announced today that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. In a Federal Register notice, the agency invites the public to provide information and share views on a wide range of topics, from product content to advertising and marketing.
FDA Confirms E. Coli O157:H7 in Prepackaged Nestlé Toll House Refrigerated Cookie Dough
Tue, 30 Jun 2009 00:35:00 -0000
Today, the U.S. Food and Drug Administration announced that it has found E. coli O157:H7 (a bacterium that can cause serious food borne illness) in a sample of prepackaged Nestlé Toll House refrigerated cookie dough currently under recall by the manufacturer and marketer, Nestlé USA. The contaminated sample was collected at Nestlé’s facility in Danville, Va. on June 25, 2009.
U.S. Attorney News Release: Ringleader Sentenced to Nine Years In Federal Prison For Allergy Testing Health Care Fraud Scheme That Bilked Insurance Companies and Deceived Thousands of Patients
Mon, 29 Jun 2009 04:00:00 -0000
A registered nurse who directed an allergy testing health care fraud scheme, was sentenced to nine years in prison and ordered to pay $2.6 million in restitution, federal law enforcement officials announced today. John Froelich, 52, formerly of Harwood Heights, was the ringleader among nine defendants who pleaded guilty to federal charges for submitting fraudulent bills totaling $11.5 million to more than 200 insurance companies, which paid approximately $2.6 million in false claims.
Company Recalls Various Products Due to Potential Salmonella Contamination
Sun, 28 Jun 2009 19:46:00 -0000
FDA, USDA, CDC investigating; no link to human illnesses at this time. Plainview Milk Products Cooperative, Plainview, Minn., is voluntarily recalling all instant nonfat dried milk, whey protein, fruit stabilizers, and gums (thickening agents) that it has manufactured over the past two years, because they might be contaminated with Salmonella.
Food and Drug Administration--Recalls
Stop & Shop Issues A Voluntary Recall of Stop & Shop Non Fat Dry Milk
Wed, 01 Jul 2009 23:50:00 -0000
Following notification from its manufacturer, The Stop & Shop Supermarket Company has recalled the following Stop & Shop Non Fat Dry Milk products...
North Coast Seafood is recalling Fresh Tuna Steaks sold in Retail Store in New England
Wed, 01 Jul 2009 18:23:00 -0000
North Coast Seafood has voluntarily removed from sale Fresh Tuna Steaks that were sold at Shaw’s, Star Market and Big Y Stores in New England
City Baking Brand Apple Crumb Cake
Sat, 27 Jun 2009 15:01:00 -0000
City Baking LLC, of Long island City, NY is recalling 781 individually wrapped City Baking brand Apple Crumb Cakes, because they contain Walnuts, which were inadvertently omitted from the label.
Food and Drug Administration - Ensures that food is safe and wholesome, that cosmetics will not do harm, and that medicines, medical devices, and radiation-emitting consumer products such as microwave ovens are safe and effective.
Meta Description: [ Home Page for the Food and Drug Administration (FDA) ]
Technology (NCFST) - A consortium of leading food companies, the U.S Food and Drug Administration, Illinois Institute of Technology, and university-based scientists working together to ensure the safety of food processing and packaging technologies.
Meta Description: [ National Center for Food Safety and Technology ]
Fact Sheets and Press Releases - Food and nutrition press releases and fact sheets.
Meta Description: [ press releases and other announcements ]
FDA Consumer Magazine - Official bimonthly, subscription magazine of the Food and Drug Administration. Offers a wealth of new and in-depth information on how to get healthy and stay healthy. It also reports on current FDA activities to ensure that the products the agency regulates are fit to use.
Meta Description: [ FDA Consumer magazine offers you a wealth of new and in-depth information on how to get healthy and stay healthy. ]
FDA Enforcement Report - Searchable index of reports published weekly by the Food and Drug Administration. It contains information on actions taken in connection with agency Regulatory activities.
Meta Description: [ Index of FDA Enforcement Reports ]
Food and Drug Administration - Publications - Links to a wide variety of FDA publications, manuals, references, industry guidance and other documents of an Agency-wide nature. Links to the FDA's centers that have publications of their own specifically related to the products they regulate.
Meta Description: [ FDA Reference Room: Links to FDA Regulations, Manuals, References, Industry Guidance, and More. ]
Food and Drug Administration - Recalls and Safety Alerts - List of recalls, alerts, and warnings of foods, drugs, medical devices, and cosmetics.
Meta Description: [ List of recalls, market withdrawals, alerts, and warnings of foods, drugs, medical devices, and cosmetics. ]
Joint Institute for Food Safety and Applied Nutrition - FDA partnership with the University of Maryland that will provide the scientific basis for ensuring a safe, wholesome food supply as well as provide the infrastructure for contributions to national food safety programs and international food standards.
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