FDA Webview
Animal Drugs
Sierra and a sister company, Veterinary Pharmaceuticals, Inc., signed the consent decree, agreeing t...
Animal Drugs
In a 3/15 editorial, the increasingly influential newspaper cited a European Union ban on subtherape...
Medical Devices
FDA grants a humanitarian-use device designation to Cyberkinetics Neurotechnology Systems for its An...
FDA General
From a long FDA career of massaging regulated industry into compliance -- sometimes a little rough...
FDA General
Consulting editor John Scharmann receives an FOI response from FDA that is five years late and says ...
Human Drugs
FDAs Oncologic Drugs Advisory Committee votes to not recommend approval for a Genta NDA for leukemia...
Human Drugs
Like its parent corporation, Schering, a week before it, now Berlex Labs has received a Warning Lett...
Human Drugs
With electronic submission standards and processes in place, FDA's Center for Drug Evaluation and Re...
Human Drugs
Parkinson's disease patients whose medications for their movement disorders often cause psychotic sy...
Human Drugs
FDA has approved a Duramed ANDA for oxycodone with acetaminophen capsules, 5mg/500mg. The company sa...
Human Drugs
Adolor Corp. says FDA has accepted its IND for use of ADL 10-0101, a peripheral nervous system-selec...
Human Drugs
FDA 3/1/99 approved an Apotex ANDA suitability petition for foscarnet sodium injection, 12mg/ml, 250...
Human Drugs
CDC says FDA has helped manufacturers prepare to ship a record volume of flu vaccine this season.
Human Drugs
Merck's cholesterol-lowering drug Mevacor (lovastatin) has gained an additional indication -- redu...
Human Drugs
FDA is giving manufacturers of over-the-counter analgesic/antipyretic drug products until 10/22 inst...
Medical Devices
Boston Scientific acknowledges an internal study found an increased risk of late stent thrombosis wi...
Federal Register
Federal Register Notice: FDA releases a draft guidance on frequently asked questions about commercia...
Human Drugs
FDA has drafted procedures for drug and biologic sponsors to follow in requesting formal meetings to...
Human Drugs
Pharmaceutical Research and Manufacturers (PhRMA) and the American Academy of Pediatrics have filed ...
Human Drugs
An appeal to FDA OMBudsman AmANDA Norton by Stephen D. Mumford, a shipper of quinacrine for non-surg...
