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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Cayenne Co., Steven J. Morgan, Olga Ostroumova, Thermoplastic Comfort Systems.

FDA Lifts Clinical Hold on Alzheimers Drug

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FDA lifts a six-month clinical hold on Cortex Pharmaceuticals investigational drug Ampakine CX717 for treating Alzheimers disease....

Committee Members Want Major FDA Safety Changes

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Current and former members of FDAs drug safety advisory committee say there are major problems with the agencys approach to drug s...

New ADHD Drug Approvable

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FDA says New River Pharmaceuticals NRP104 candidate for once-daily treatment of ADHD in children six to 12 is approvable.

FDA OKs Merial Equine Ulcer Treatment

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Federal Register Final rule: FDA approves a Merial Ltd. supplemental NADA for administering omeprazole to horses for preventing ga...

Drug Companies Spending on Ads Again

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TNS Media Intelligence says drug company spending on consumer ads rose 9% in the first half of this year.

Extensive IT Use Yields High Level of Manufacturing Performance

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The Pharmaceutical Research Manufacturing Project says extensive use of information technology is associated with superior manufac...

Sepracor NDA Approved for COPD

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FDA approves a Sepracor NDA for Brovana inhalation solution as a twice-daily treatment for patients with chronic obstructive pulmo...

Workshop on Sex Differences in Critical Path

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Federal Register Notice: FDAs Office of Womens Health plans a workshop on sex differences and the FDA Critical Path Initiative.

OGD Adopts New Drug e-Document System

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CDERs Office of Generic Drugs adopts an Office of New Drugs electronic file system for more efficient reviews and archiving.