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Location Changed for Endocrinologic Panel Meeting

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Federal Register Notice: FDA amends a notice of an 11/8 Endocrinologic and Metabolic advisory committee meeting to change the loca...

VuComp PMA Approved for Mammography CAD System

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FDA approves a VuComp for its M-Vu CAD system (version 2) for digital mammography.

Drug Industry Comments on Suicidality in Clinical Trials

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Drug company comments offer revisions and clarification points on FDAs draft guidance on Suicidal Ideation and Behavior: Prospecti...

CDER Moving Forward with REMS Standardization, Guidance

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CDER associate director for drug safety operations Theresa Toigo discusses the Centers efforts to standardize REMS programs and de...

FDA Panel Mixed on Genzyme Cholesterol NDA

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FDAs Endocrinologic and Metabolic Drugs Advisory Committee gives a mixed vote on Genzymes Kynamro (mipomersen sodium) for treating...

FDA Expands Indication on Sapien Transcatheter Heart Valve

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FDA expands the approved indication on Edwards Lifesciences Sapien Transcatheter Heart Valve to include patients with aortic valve...

Location Changed for Nonprescription Drugs Panel Meeting

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Federal Register Notice: FDA changes the location and contact name for a 11/9 meeting of the Nonprescription Drugs Advisory Commit...

Aeterna Zentaris to File NDA for Growth Hormone Deficiency

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Aeterna Zentaris presents positive data for its oral diagnostic test for adult growth hormone deficiency and plans an early 2013 N...

ThromboGenics NDA for Eye Drug Approved

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FDA approves a ThromboGenics NDA for Jetrea, the first drug approved to treat an eye condition called symptomatic vitreomacular ad...

Sanofi Pasteur Files sBLA for Quadrivalent Fluzone

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Sanofi Pasteur files a supplemental BLA with FDA for a quadrivalent formulation of its Fluzone (influenza virus vaccine).