» FDA expands use for FilmArray Respiratory Panel
15/05/12 17:29 from Food and Drug Administration
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
10/05/12 12:58 from Food and Drug Administration
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 tr..

» FDA proposal aims to help reduce unnecessary radiation exposure for children
09/05/12 13:00 from Food and Drug Administration
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 In the draft guidance, FDA is re..

» FDA issues final rule on sterility testing of biological products
03/05/12 17:52 from Food and Drug Administration
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
01/05/12 21:52 from Food and Drug Administration
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 duri..

» FDA approves new orphan drug to treat a form of Gaucher disease
01/05/12 20:09 from Food and Drug Administration
The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.

» FDA approves new antibacterial treatment for plague
30/04/12 13:24 from Food and Drug Administration
The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after expo..

» FDA challenges marketing of DMAA products for lack of safety evidence
27/04/12 18:56 from Food and Drug Administration
The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the saf..

» FDA approves Stendra for erectile dysfunction
27/04/12 17:47 from Food and Drug Administration
The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

» FDA approves Votrient for advanced soft tissue sarcoma
26/04/12 21:47 from Food and Drug Administration
The U.S. Food and Drug Administration today approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous..

» FDA approves Afinitor for non-cancerous kidney tumors caused by rare genetic disease
26/04/12 20:33 from Food and Drug Administration
The U.S. Food and Drug Administration today approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosi..

» FDA Statement on USDA Announcement of Positive BSE Test Result
26/04/12 13:20 from Food and Drug Administration
This week, the U.S. Department of Agriculture (USDA) confirmed that a dairy cow in California tested positive for atypical bovine spongiform encephalopathy (BSE, or "mad cow" disease). The USDA also confirmed the cow did not enter the anima..

» FDA strengthens international collaboration to ensure quality, safety of imported products
23/04/12 12:54 from Food and Drug Administration
The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report” [INSERT HYPERLINK], detailing the many activities and strategies FDA is using to transform from a domestic t..

» Report: FDA strengthens monitoring of post-approval drug safety
21/04/12 17:03 from Food and Drug Administration
A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released tod..

» FDA issues draft guidance on nanotechnology
20/04/12 17:24 from Food and Drug Administration
Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.

» U.S. Marshals seize ultrasound gel product at a New Jersey company
18/04/12 17:50 from Food and Drug Administration
U.S. Marshals, acting at the request of the Food and Drug Administration, today seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J. after an FDA analysis found that product sampl..

» Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product
13/04/12 22:54 from Food and Drug Administration
• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically..

» Dept. of Justice enters consent decree with California seafood processor
11/04/12 20:10 from Food and Drug Administration
A California seafood importer and processor has agreed to a consent decree with the FDA that prevents the company from manufacturing or distributing fish or fish products until it has corrected conditions in its seafood processing facility ..

» FDA takes steps to protect public health
11/04/12 15:34 from Food and Drug Administration
The U.S. Food and Drug Administration announced today that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals.

» FDA approves imaging drug Amyvid
10/04/12 20:26 from Food and Drug Administration
Estimates brain amyloid plaque content in patients with cognitive decline