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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.

Enrollment Complete for Provenge Study

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Dendreon completes enrollment in a Provenge Phase 3 study needed to provide additional efficacy data to FDA.

Antibiotics Article Was Not Falsely Based

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Consulting editor John Scharmann replies to a critic who alleged there were two false premises in a recent article about animal an...

FDA OKs Suns Generic Exelon

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FDA approves a Sun Pharmaceutical Industries ANDA for a generic version of Novartis's Exelon caspsules, indicted for treating Alzh...

FDA Seeks Enrollment Stop in Delcath Trials

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FDA suggests a temporary enrollment suspension in Delcath System Phase 2 and 3 trials due to safety concerns.