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FDA Wants More Data on Needle-free Fuzeon

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Roche and Trimeris delay an amended supplemental NDA for a needle-free administration of HIV therapy Fuzeon after FDA requests add...

Disagreement on FDAs Nanotechnology Needs

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An FDA-sponsored public meeting on nanotechnology, draws conflicting testimony on the need for new legal/regulatory authorities.

DeCode Suspends Trial Due to Manufacturing Concern

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DeCode Genetics suspends a Phase 3 clinical trial involving its heart attack prevention drug in order to address an unexpected for...

CGMP Problems Found at Thermoplastic

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An FDA Warning Letter cites 14 CGMP problems found in an inspection at Irvine, CA-based Thermoplastic Comfort Systems.

FDA OKs Mercks Skin Cancer Drug

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FDA approves Mercks Zolinza (vorinostat), a once-daily drug for treating cutaneous manifestations in patients with cutaneous T-cel...

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.

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.