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Nominations Sought for Tobacco Panel

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Federal Register Notice: FDA requests nominations for voting members to serve on the Tobacco Products Scientific Advisory Committe...

FDA Guidance on Acute Bacterial Sinusitis Drugs

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A new CDER guidance outlines drug development considerations for products indicated for treating acute bacterial sinusitis.

Agency OKs TriVascular Abdominal Stent Graft

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FDA approves a TriVascular PMA for the Ovation Abdominal Stent Graft System for treating abdominal aortic aneurysms.

FTC Seeks High Court Review in Androgel Settlement

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The FTC petitions the U.S. Supreme Court to review a recent federal appeals court ruling concerning its case against a pay-for-del...

12 New and Revised Med Guides Posted

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FDA posts six new and six revised Medication Guides.

Apotex Sues FDA Over Compliance Status Report Failure

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Apotex files suit against FDA charging that the agencys alleged failure to record the compliance status of its manufacturing facil...

FDA Iron Sucrose Guidance Challenged

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Luitpold Pharmaceuticals and four patient advocacy groups question an FDA draft guidance on determining bioequivalence for generic...

FDA Posts August NADA Approvals

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Federal Register Final rule: FDA amends the animal drug regulations to reflect August NADA approvals and to reflect sponsor change...

FDA Posts Approved PMAs

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Federal Register Notice: FDA publishes a list of approved PMAs and their safety and effectiveness summaries.

Drug Companies Obliged to Publicize Drug Risks: Kessler

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Former FDA commissioner David Kessler says that doctors are unduly influenced by drug company promotional activities.