FDA Webview
X
latest-news-card-1
Animal Drugs

Sierra and a sister company, Veterinary Pharmaceuticals, Inc., signed the consent decree, agreeing t...

latest-news-card-1
Animal Drugs

In a 3/15 editorial, the increasingly influential newspaper cited a European Union ban on subtherape...

latest-news-card-1
Medical Devices

FDA grants a humanitarian-use device designation to Cyberkinetics Neurotechnology Systems for its An...

latest-news-card-1
FDA General

From a long FDA career of massaging regulated industry into compliance -- sometimes a little rough...

latest-news-card-1
FDA General

Consulting editor John Scharmann receives an FOI response from FDA that is five years late and says ...

latest-news-card-1
Human Drugs

FDAs Oncologic Drugs Advisory Committee votes to not recommend approval for a Genta NDA for leukemia...

latest-news-card-1
Human Drugs

Like its parent corporation, Schering, a week before it, now Berlex Labs has received a Warning Lett...

latest-news-card-1
Human Drugs

With electronic submission standards and processes in place, FDA's Center for Drug Evaluation and Re...

latest-news-card-1
Human Drugs

Parkinson's disease patients whose medications for their movement disorders often cause psychotic sy...

latest-news-card-1
Human Drugs

FDA has approved a Duramed ANDA for oxycodone with acetaminophen capsules, 5mg/500mg. The company sa...

latest-news-card-1
Human Drugs

Adolor Corp. says FDA has accepted its IND for use of ADL 10-0101, a peripheral nervous system-selec...

latest-news-card-1
Human Drugs

FDA 3/1/99 approved an Apotex ANDA suitability petition for foscarnet sodium injection, 12mg/ml, 250...

latest-news-card-1
Human Drugs

CDC says FDA has helped manufacturers prepare to ship a record volume of flu vaccine this season.

latest-news-card-1
Human Drugs

Merck's cholesterol-lowering drug Mevacor (lovastatin) has gained an additional indication -- redu...

latest-news-card-1
Human Drugs

FDA is giving manufacturers of over-the-counter analgesic/antipyretic drug products until 10/22 inst...

latest-news-card-1
Medical Devices

Boston Scientific acknowledges an internal study found an increased risk of late stent thrombosis wi...

latest-news-card-1
Federal Register

Federal Register Notice: FDA releases a draft guidance on frequently asked questions about commercia...

latest-news-card-1
Human Drugs

FDA has drafted procedures for drug and biologic sponsors to follow in requesting formal meetings to...

latest-news-card-1
Human Drugs

Pharmaceutical Research and Manufacturers (PhRMA) and the American Academy of Pediatrics have filed ...

latest-news-card-1
Human Drugs

An appeal to FDA OMBudsman AmANDA Norton by Stephen D. Mumford, a shipper of quinacrine for non-surg...