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FDA Warns 2 Foreign API Firms

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FDA warns API manufacturing facilities in Japan and China over significant CGMP deviations.

FDA Not Moved by New Plavix Study

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FDA says it is working on a new public communication to reiterate a warning on Sanofi-Aventis' drug Plavix (clopidogral bisulfate)...

MannKind Cancer Vaccine Study Starts

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MannKind says the first patient has been dosed in a Phase 2 trial of its MKC1106-MT cancer vaccine targeting advanced melanoma.

Buspar Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Buspar tablets were not withdrawn for reasons of safety or effectiveness.

Panel to Discuss Weight Loss Drug

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Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 12/7 to discuss Orexigen Therapeutic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Advanced Testing Laboratory, Biostructures, Choksi Laboratories, Contract Pharma...

Immune Works Begins Trial in Lung Disease Patients

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ImmuneWorks has initiated a Phase 1 clinical trial using its IW001 (purified bovine Type V collegen solution) in patients sufferin...

Phase 3 Study on Sepsis Device

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Spectral Diagnostics begins a Phase 3 study involving its hemoperfusion device, Toraymyxin, to evaluate its effectiveness in remov...

FDA Outlines 'Secret' LASIK Study Details

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FDA provides an update on its plans for a three-part study to determine the percentage of LASIK laser vision-correction patients w...

Patients Dont Want Docs Taking Drug Company Money

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ProPublica says a Consumer Reports survey finds that many patients are concerned about a potential conflict of interest if their d...