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FDA Wants Post-approval Study on Abbott Stent

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FDA briefing documents released before this weeks advisory committee review of Abbotts Xience drug-eluting stent support approval ...

FDA Clears Amedica Pedicle Screw System

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FDA clears an Amedica Corp. 510(k) for the Valeo Pedicle Screw System.

Latest EIRs/483s from FDA Posted

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We post to our Web site the latest FDA-483s and EIRs, etc. we have received from FDA, for Canfield Inc., GRE Fulfillment, Minntech...

Court Nixes Provenge Case

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An Ohio federal court says it cant review FDAs May decision not to approve Dendreons Provenge because it is not a final decision....

FDA Corrects Notice on BTC Drugs

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Federal Register Notice: FDA corrects a date in a notice announcing a public meeting to obtain comments on behind-the-counter avai...

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...

FDA Signs CRADA with Ingenuity Systems

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FDA signs a cooperative research and development agreement with Ingenuity Systems to expand its content and software solutions.

Latest FDA Warning Letters

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In its latest weekly batch of posted Warning Letters, FDA cites clinical investigator Alan Rapoport.

FDA Accepts Vanda NDA on Antipsychotic

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FDA accepts for review a Vanda Pharmaceuticals NDA for iloperidone, an investigational atypical antipsychotic indicated for treati...