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Policy of Silence: Is This How FDA Lost Public Respect?

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FDA Webview editor Jim Dickinson reviews FDAs falling public respect in light of recent changes in its media communications and fi...

Latest FDA-483s, EIRs, etc. Received from FDA

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We post to our Web site the latest FDA-483s, EIRs, and related documents received from FDA for Canady Technology, Cardiovascular I...

Court Sides With FDA in Generic Wellbutrin Case

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The Washington DC District Court rejects a Biovail-sought temporary restraining order to compel FDA to resolve issues raised in th...

FDA Panel Goes Against Factive Expanded Use

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FDAs Anti-Infective Drugs Advisory Committee votes against recommending approval of an expanded indication for Oscient Pharmaceuti...

FDA OKs Alpharma sNADA for Cattle Feed

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Federal Register Final rule: FDA approves an Alpharma, Inc. supplemental NADA for using chlortetracycline to formulate medicated f...

Von Es Nomination Moves On in Senate

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The Senate HELP Committee resumes 9/20 its deliberations on the previously blocked nomination of FDA acting commissioner Andrew vo...

FDA Funds C-Path Genetic Test Evaluations

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FDA awards a $675,000 grant to the Critical Path Institute to allow scientists to evaluate genetic tests for determining existing ...

Uroplastys PMA on Urinary Incontinence Bulking Agent Approvable

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FDA issues Uroplasty, Inc. an approvable letter for its PMA on Macroplastique implants intended to treat female stress urinary inc...

CDER Consolidates GRPs on Web Site

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CDER posts all good review practice guidances and policies to a single Web page.

FDA Outlines Requirements for Tissue Processors

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A new FDA guidance outlines responsibilities for firms to comply with current good tissue practice requirements when they enter in...