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Kennedy Blasts Political Winds at FDA

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Incoming Senate Health, Education, Labor and Pensions Committee chairman Ted Kennedy blasts politicization of FDA at a hearing on ...

FDA Priority Review for GSKs Tykerb

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FDA grants priority review to GlaxoSmithKlines Tykerb for use in combination with Roches Xeloda in treating advanced or metastatic...

FDA Clears Blood Glucose Data System

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FDA clears an AgaMatrix, Inc. 510(k) for its Zero-Click Blood Glucose Data Management System.

Medtronic PMA Submitted for Endeavor Stent

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Medtronic submits the final modules of a PMA for its Endeavor drug-eluting coronary stent system.

Hearing Set on Regulatory Info Submission

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FDA solicits public opinion on an a potential agency mandate for electronic submission of product information.

Allergans Lap-Band Goes DTC

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Allergan turns to DTC ads for its Lap-Band weight loss system.

Clinical Hold Lifted for Lupus Drug

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FDA lifts its clinical hold on trials of Immunomedics epratuzumab in lupus patients.

Avoiding FDA Compliance Issues with Steve Niedelman

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Consulting editor John Scharmann reports on an Avoiding FDA Compliance Issues teleconference with former deputy associate commissi...