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3 Health Affairs Articles Address Drug Issues

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Researchers writing in Health Affairs discuss clinical trial registration, off-label marketing, and controls on use of atypical an...

Panel Supports Expanded Indication for Medtronic CRT-D Devices

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FDAs Circulatory Systems Devices Panel votes that Medtronics cardiac resynchronization therapy with implantable cardioverter defib...

FDA OKs Watson/Antares NDA for Overactive Bladder

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FDA approves a Watson and Antares Pharma NDA for a topical oxybutynin gel 3% product to treat overactive bladder.

Advisors Back Pfizers Axitinib for Kidney Cancer

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FDAs Oncologic Drugs Advisory Panel recommends Pfizers axitinib for treating some advanced renal cell carcinoma patients.

FDA Responsive to Artificial Pancreas Concerns: Advocates

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JDRF praises FDA for responding to its concerns about a draft artificial pancreas study guidance.

Public Meeting on Generic Drug User Fee Act

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Federal Register Notice: FDA plans a public meeting 12/19 to discuss the proposed recommendations for enacting a Generic Drug User...

LifeScience Alley, CDRH Sign MOU

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Trade association LifeScience Alley and CDRH sign a memorandum of understanding to advance regulatory science.

Reviewers Raise Adasuve Safety Concerns

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FDA medical reviewers ask members of the Psychopharmacologic Drugs Advisory Committee to determine whether the benefits of Alexzas...

Plan B Decision Supports Authoritarian Control of America

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Editor Jim Dickinson sees in HHS secretary Kathleen Sebelius decision to over-rule FDA on Plan B a continuation of Bush-era author...

Generic Drug User Fee Legislation Expected Next Year

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Attorney Kurt Karst outlines elements in an agreement reached between FDA and the generic drug industry on a generic drug user fee...