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Avastin Labeling Strengthened

[ Price : $8.95]

FDA says new risk information has been added to Avastins labeling.

Alphatec Wins 'Close-out' on 2010 Warning Letter

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Alphatec Holdings says it has resolved a 2010 Warning Letter that cited the company's Carlsbad, CA, facility over quality system r...

Advocacy Groups Want to Help Define Risk

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NORD and other patient advocates ask FDA to create opportunities for patient input on some risk/benefit deliberations.

Merck, Ariad NDA for Sarcoma Therapy

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FDA accepts for review a Merck and Ariad Pharmaceuticals NDA for ridaforolimus for treating metastatic soft-tissue or bone sarcoma...

Info on Bioequivalence Data Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on submitting bioequivalence data to the Office of Manag...

Columbia U. Improperly Used Radioactive Drugs: FDA

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FDA warns Columbia University Medical Center about failures of its Radioactive Drugs Research Committee to assure the safety of ra...

Yaupon Therapeutics NDA for Mechlorethamine

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FDA accepts for filing a Yaupon Therapeutics NDA for its proprietary gel formulation of mechlorethamine hydrochloride, indicated f...

FDA Clears Bioness Hand Rehab System

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FDA clears a Bioness 510(k) for its NESS H200 Wireless Hand Rehabilitation System.

CDRH Wants Outside Expert Help

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CDRH says it wants comments on a proposal to create a Network of Experts to provide quick staff access to specific specialized kno...

Combined Hormonal Contraceptive Study Results Due

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FDA says a 12/8 joint meeting of two advisory committees will discuss final results from an agency-funded study of cardiovascular ...