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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...
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...
Human Drugs
FDA has approved Endo Pharmaceuticals' Lidoderm (lidocaine patch 5%), a patch dermal delivery system...
Human Drugs
Because some generic drug sponsors have submitted sloppy and disorganized ANDAs, CDER's Office of Ge...
Human Drugs
An International Conference on Harmonization meeting last week in Brussels reports that its work on ...
Human Drugs
The Institute of Medicine's report entitled "Marijuana and Medicine: Assessing the Science Base" was...
Human Drugs
OTC drug manufacturers welcome a new FDA regulation for their products that establishes a standardiz...
Human Drugs
Phase III clinical trial results for rheumatoid arthritis patients taking Immunex Corp.s Enbrel (eta...
Human Drugs
New technology like liquid chromotography/mass spectometry is not adequately addressed in FDA's Bioa...
