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Former FDAer Testifies in Paxil Trial

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A former FDA drug safety official tells a product liability trial jury in Philadelphia that GlaxoSmithKline had complied with all ...

Allergan Sues to Share Truthful Off-label Information

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Allergan asks a federal court for a ruling permitting it to share truthful information about off-label Botox therapies with doctor...

Appeals Court Supports FDA Anthrax Vaccine OK

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A federal appeals court says FDA properly approved the anthrax vaccine and the Defense Department may administer it to members of ...

FDA Plans Second Transparency Public Meeting

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FDA plans a second public meeting 11/3 to receive comments on how to ensure that information about certain agency activities and d...

FDA Update on Calcium Disodium Versenate Shortage

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FDA says a drug shortage involving Graceway Pharmaceuticals calcium disodium versenate injection 200 mg/mL 5 mL ampules should be ...

Recent Preemption Cases Support Restrictive Approach

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Law school professor Richard Cupp says that recent Supreme Court decisions show a trend toward a conservative and restrictive appr...

U.S. Government Defends FDA Tobacco Regulation

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The U.S. government says that restrictions in FDAs regulation of tobacco products that are being challenged by tobacco companies i...

PegIntron Doesnt Improve Overall Melanoma Survival: FDA

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FDA asks the Oncologic Drugs Advisory Committee whether the benefit of Scherings PegIntron in providing some relapse-free survival...

CSPI Sues Bayer Over Vitamin Selenium Cancer Claim

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The Center for Science in the Public Interest sues Bayer for refusing to remove all ad claims for Mens One A Day multivitamins cla...

Combo Products Postmarket Regs Proposed

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Federal Register Proposed rule: FDA proposes postmarketing safety reporting requirements for combination products.