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FDA Tries Again with Non-secret Hemopure Meeting

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FDA reschedules a previously secret advisory committee meeting involving a U.S. Navy proposal to test Biopures experimental blood ...

Basketball Great Frazier in Program for Actos

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Former pro basketball player Walt Frazier participates in an American Heart Association diabetes education program on cardiovascul...

Analysts See FDA Approving More Drugs

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Financial analysts see a trend in FDA increasing the number of NDA and NME approvals.

A Law Change to Stop Farm Antibiotic Generics?

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Consulting editor John Scharmann says FDA has no choice but to approve growth-promoting antibiotic generics and wonder whether Con...

Fix DDMAC Before Funding with Fees: Coalition

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The Coalition for Healthcare Communication says its concerns about DDMAC ad reviews should be addressed before talk of user fees.

Glaxo Backs Diabetes Education Program

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GlaxoSmithKline sponsors a nationwide diabetes education campaign featuring life and fitness coach Bob Harper.

Aqueous Biomedical Warned on Clinical Studies

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CDRH warns Aqueous Biomedical over IDE regulation violations during a clinical study.

Pfizer Pulls Out of Asenapine Development Pact

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Pfizer backs out of its partnership with Organon to develop asenapine for treating schizophrenia and Bipolar I Disorder.

Novartis NDAs Filed on Tasigna, Aclasta

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Novartis says it has submitted NDAs ahead of schedule for Tasigna, indicated for treating certain chronic myeloid leukemia patient...

FDA Concerned by Lack of Microarray Standards

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CDER associate director for genomics Felix Freuh sees a lack of standards as threatening future growth of microarray data in regul...