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Aegerion Pharma CEO Cited for Statements on CNBC

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FDA objects to statements made by Aegerion Pharmaceuticals CEO Marc Beer on CNBCs Fast Money program that it says broadened the in...

Drug Products Not Withdrawn for S&E

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Federal Register Notice: FDA determines that several drug products were not withdrawn from sale for reasons of safety or effective...

Erytech Pharma Gets OK from Monitoring Board for Leukemia Drug

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Erytech Pharma says an independent Data and Safety Monitoring Board completed its first assessment of a Phase 2b study evaluating ...

Study Backs Pediatric Cough Cold Medicine Re-Labeling

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A Centers for Disease Control and Prevention study says emergency department visits associated with OTC pediatric cough cold medic...

Panel to Discuss BMS NDA for Diabetes

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 12/12 to discuss a Bristol-Myers Squ...

Panel to Vote on Cardiac Implant

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 12/11 to vote on a Boston Scientific PMA for the WATCHMAN...

FDA Clears Topera FIRMap Catheter

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FDA clears a Topera 510(k) for its FIRMap Catheter for use on its 3D Mapping System to identify a patients hearts electrical activ...

FDA Proposes Generic Drug Safety Labeling Changes

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FDA issues a proposed rule to require generic drug makers to use the same process as brand drug manufacturers to update safety inf...

FDA Approves Generic Aciphex Copies

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FDA approves the first generic versions of Eisais Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesopha...

Sanofi Sues FDA Over Nasacort OTC Labeling Release

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Sanofi sues FDA seeking to block the release of the approved drug label for its over-the-counter Nasacort Allergy 24-hour nasal sp...