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CBER Updates Electronic Format Guidance

[ Price : $8.95]

CBER updates its guidance on providing lot release protocols in electronic format to remove references to outdated technology.

Comments Extended on Sunscreen Monograph

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Federal Register Proposed rule: FDA extends to 12/26 the comment period for a proposed rule to amend the OTC sunscreen drug produc...

FDA Wants Another Phase 2 Study on Acne Scar Therapy

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Isolagen says it is modifying an ongoing Phase 3 trial for acne scar treatment Isolagen Therapy to address concerns FDA recently r...

FDA Clears 2 Merit Medical Products

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FDA clears Merit Medicals All Star hemostasis valve and Prelude marker tip introducer sheath.

Smith & Nephew Recalls Knees

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Smith & Nephew says it is recalling knees from three ranges due to a higher-than-specified iron content.

FDA Panel to Review Heartmate II PMA

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FDAs Circulatory System Devices Panel meets 11/30 to vote on whether to recommend approval of Thoratec Corp. HeartMate II Left Ven...

Committee to Consider Entereg NDA

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FDAs Gastrointestinal Drugs Advisory Committee schedules a review of Adolors NDA for Entereg for short-term treatment of post-oper...

Consensus Algorithm Seeks More Avandia Caution

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A diabetes management consensus statement calling for greater caution in prescribing GlaxoSmithKlines Avandia is challenged by the...

Bristol Scraps Plans on Bladder Cancer Agent

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Bristol-Myers Squibb kills a licensing deal with Pierre Fabre Medicament to seek FDA approval for vinflunine, an investigational a...

FDA Seeks Risk Analysis on Pediatric Asthma Drug Use

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FDA safety reviewers recommend a thorough risk-benefit analysis on pediatric use of GlaxoSmithKlines Serevent and Advair, and Nova...