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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...

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...

FDA OKs Intervet sNADA for Horse Feed

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Federal Register Final rule: FDA approves an Intervet sNADA to revise food safety warnings on fenbendazole medicated horse feeds.

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.

Fetal Risk Warning Added to Myfortic

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Novartis and FDA warn against the use of Myfortic delayed-release tablets during pregnancy due to increased risks of pregnancy los...

Cardinal Recalls Alaris Pump Modules

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Cardinal Health recalls Alaris pump modules due to the potential for inaccurate flow rate from a misassembled spring.

FDA-Duke Work on Modernizing Clinical Trials

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FDA is collaborating with Duke University Medical Center on a public-private partnership to find ways to modernize clinical trials...

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 ...