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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

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

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Human Drugs

FDA has approved Endo Pharmaceuticals' Lidoderm (lidocaine patch 5%), a patch dermal delivery system...

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Human Drugs

Because some generic drug sponsors have submitted sloppy and disorganized ANDAs, CDER's Office of Ge...

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Human Drugs

An International Conference on Harmonization meeting last week in Brussels reports that its work on ...

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Human Drugs

The Institute of Medicine's report entitled "Marijuana and Medicine: Assessing the Science Base" was...

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Human Drugs

OTC drug manufacturers welcome a new FDA regulation for their products that establishes a standardiz...

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Human Drugs

Phase III clinical trial results for rheumatoid arthritis patients taking Immunex Corp.s Enbrel (eta...

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Human Drugs

New technology like liquid chromotography/mass spectometry is not adequately addressed in FDA's Bioa...