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FDA Creates Pediatric Review Committee

[ Price : $8.95]

FDA creates a Pediatric Review Committee to look at pediatric information submitted in pediatric plans, assessments, and studies.

FDA Clears Vertebrae Fusion Support System

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FDA clears an Alphatec Holdings 510(k) for the Dynamo Rod System, intended for use in vertebrae fusion surgeries.

Gardasil New Brand of the Year

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DTC Perspectives Gold Perspectives on Excellence Award goes to Mercks Gardasil as Best New Brand of the Year.

Bayers Trasylol Dealt Another Blow

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FDA says it is re-evaluating the overall risks and benefits of Bayers anti-bleeding drug Trasylol after new data show higher fatal...

Guidance on Drug-Induced Liver Injury

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Federal Register Notice: FDA releases a draft guidance on premarketing clinical evaluation on drug-induced liver injury.

Guidance on In Vitro Diagnostic Device Studies

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Federal Register Notice: FDA releases a draft guidance with frequently asked questions on in vitro diagnostic device studies.

Guidance on Product-Specific BE Recommendations

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Federal Register Notice: FDA makes available bioequivalence recommendations for specific products on the design of studies to supp...

DTC User Fee Program Detailed

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Federal Register Notice: FDA explains the new direct-to-consumer user fee program.

Info on Blood CGMPs OKd by OMB

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on CGMP for blood and compo...

Workshop on Pandemic Vaccine Development

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Federal Register Notice: FDA plans a public workshop 12/10-11 on the immune correlates of protection against Influenza A viruses i...