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Food and Drug Administration Press Releases
Press releases from FDA
FDA Approves New Formulation of Coagulation Therapy
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.
FDA Approves First Generic Ropinirole
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega For...
The U.S. Food and Drug Administration's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" has detected hazardous amounts of chromium.
Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc.
FDA Embarks on Major Hiring Initiative for its Public Health Mission
The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.
FDA Approves Amitiza for IBS-C
The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over.
Coronary Artery Plaque Imaging Device Cleared by FDA
The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.
FDA Approves Relistor for Opioid-Induced Constipation
The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.
FDA Orders Pet Food Maker to Obtain Emergency Operating Permit
The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog and Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce.
FDA Proposes Recommendations for Two Animal Drug Funding Programs
The U.S. Food and Drug Administration has delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs.
FDA Strengthens Safeguards for Consumers of Beef
The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease").
FDA Clears Glove Made from New Type of Latex
The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States.
FDA Approves Cimzia to Treat Crohn's Disease
A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies.
FDA Approves First Compact Heart Assist Device
The U.S. Food and Drug Administration today approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant.
Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Ce...
The recalled products were distributed nationally under the Malt-O-Meal brand name as well as under private label brands including Acme, America's Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. The cereals have "Best If Used By" dates from April 8, 2008 (coded as "APR0808") through March 18, 2009 (coded as "MAR1809").