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CBER Submissions System Hacked and IDs Stolen

[ Price : $8.95]

CBER says its online submission system was compromised 10/15 and user information was obtained by the unidentified hacker.

FDA Releases Survey on da Vinci System Experiences

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FDA releases results of its survey of 11 surgeons on their experiences using the da Vinci Surgical System.

Discovery Labs to Start Aerosurf Phase 2 Trial

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FDA approves a Discovery Laboratories IND for Aerosurf, allowing the company to launch a Phase 2 clinical trial program.

FDA Releases Burzynski Research Institute FDA-483

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FDA releases an FDA-483 from an inspection at Burzynski Research Institute.

FDA Cites Daiichi Sankyo Over Mailer to Physicians

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A just-post FDA untitled letter cites Daiichi Sankyo for making misleading claims in a mailer to health professionals for hyperten...

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Drug Products Not Withdrawn for S&E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Federal Register Notice: FDA determines that several drug products were not withdrawn from sale for reasons of safety or effective...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 ...

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...