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Prasugrel Gains Offset by Bleeding Patients

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Researchers comparing Lillys prasugrel to Plavix say prasugrel prevents as many deaths from heart disease as it causes deaths from...

Big Process Validation Remake Coming for Drugs

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CDER deputy compliance director Joseph Famulare says the agencys soon-to-be-published Process Validation Guidance builds validatio...

FDA Says Glaxo Depression Drug Not Approvable

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FDA sends Fabre-KramerPharmaceuticals and GlaxoSmithKline a not-approvable letter for their NDA for gepirone extended-release tabl...

FDA Extends User Fee Date on Sular Formulation

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FDA extends by two months its user fee action date on a SkyePharma PLC supplemental NDA on a new Sular (nisoldipine) formulation.

Welch Allyn Defibrillators Recalled

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FDA says a Welch Allyn AED 10 defibrillator recall is a Class 1 recall.

Bayer Suspends Trasylol Marketing Amid Safety Concerns

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Bayer suspends marketing of blood loss drug Trasylol (aprotinin) amid growing safety concerns after a Canadian trial is stopped du...

FDA Seeks Recall of Drug-containing Supplements

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FDA asks America True Man Health Inc. to recall all True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men'...

Device Wholesaler Must Wear FDCA Violator Shirt

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A federal judge sentences an Alabama medical device wholesaler to wear a shirt reading I was convicted of violating the FDCA.

Global Drug Market to Grow 5-6%

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IMS Health forecasts slightly lowered growth in the global pharmaceutical market next year.

FDA 3-month Extension on Regereron BLA

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FDA extends by three months a Regeneron Pharmaceuticals BLA action date for for Rilonacept (interleukin-1) trap), indicated for tr...