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Waxman Seeks Info on Medtronic Approval Shortcoming

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Rep. Henry Waxman asks FDA commissioner von Eschenbach for information relating to FDA approval of Medtronics recalled Sprint Fide...

Mylan and Glaxo Settle Paxil Litigation

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Mylan Pharmaceuticals and GlaxoSmithKline settle an ongoing patent infringement suit involving Paxil.

Guidance on Device User Fee Small Business Certification

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Federal Register Notice: FDA releases a guidance on FY 2008 medical device user fee small business qualification and certification...

Vaccines Panel to Meet

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Federal Register Notice: The Vaccines and Related Biological Products Advisory Committee will meet 11/14 to hear updates from two ...

Panels to Discuss OTC Mevacor

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Federal Register Notice: FDAs Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Arrow International, Richard Kagan, Baljit Sharma, and Trestle.

Indevus Reintroducing Valstar Early Next Year

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CDER says Indevus Pharmaceuticals plans on re-introducing Valstar (valrubicin) by early 2008, following its removal from the marke...

FDA OKs Novartis Voltaren Gel

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FDA approves a Novartis NDA for Voltaren Gel, indicated for topical use in treating osteoarthritis pain.

AdvaMed Backs FDA Device Preemption

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AdvaMed urges the Supreme Court to support FDAs regulatory authority over medical devices and not allow a state liability suit to ...

Arrow International Gets Fourth Warning Letter

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In an apparent lapse from Bush Administration policy against multiple Warning Letters to the same company, FDA sends a fourth Warn...