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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 generic versions of blood thinner Plavix
Thu, 17 May 2012 13:04:00 -0500
The U.S. Food and Drug Administration today approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.
FDA expands use for FilmArray Respiratory Panel
Tue, 15 May 2012 12:29:00 -0500
The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis
Thu, 10 May 2012 07:58:00 -0500
The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).
FDA proposal aims to help reduce unnecessary radiation exposure for children
Wed, 09 May 2012 08:00:00 -0500
Today, the U.S. Food and Drug Administration announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.
FDA issues final rule on sterility testing of biological products
Thu, 03 May 2012 12:52:00 -0500
The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.
FDA permits marketing of a new device for abdominal surgery
Tue, 01 May 2012 16:52:00 -0500
On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery. The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions (surgical cuts into body tissue) in the abdomen.
Food and Drug Administration--Recalls/Safety Alerts
Caribe Produce, LTD CO. Recalls Papaya Maradol, Caribena Brand Because Of Possible Health Risk
Fri, 18 May 2012 22:54:00 -0500
Caribe Produce LTD Co. of McAllen, TX, is recalling 286 cases of Papaya Maradol, Caribeña Brand papayas packed in 35 lb. cartons marked with the brand “ Caribeña “ and “ Product of Mexico” stamped on the side. The papayas are sold individually, and each one bears a label which states “3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO
River Ranch Recalls Retail And Food Service Salads Because Of Possible Health Risk
Fri, 18 May 2012 22:21:00 -0500
River Ranch Fresh Foods, LLC of Salinas, CA is initiating a voluntary recall of retail and foodservice bagged salads,because they have the potential of being contaminated with Listeria monocytogenes following routine random retail salad finished product tests conducted in the marketplace by the Food & Drug Administration.
WEST COAST NUTRITIONALS, LTD. Issues a Voluntary Worldwide/Nationwide Drug Recall of Products FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON due to Undeclared Tadalafil
Fri, 18 May 2012 21:47:00 -0500
WEST COAST NUTRITIONALS, LTD is conducting a voluntary recalling all lots of FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON capsules to the consumer level. An FDA lab analysis of FIRMINITE distributed by West Coast Nutritionals was found to contain undeclared Tadalafil.
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.
