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DeLauro Wants Outsourcing of Antibiotic Efficacy Tests Stopped

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Rep. Rosa DeLauro says that FDA commissioner Margaret Hamburg should immediately stop any plans to outsource antibiotic efficacy t...

Hamburg Defends H1N1 Vaccine Process

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FDA commissioner Margaret Hamburg asks healthcare professionals to reassure patients that the H1N1 flu vaccine is safe and effecti...

Comment Period Extended on CGMPs for Combo Products

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Federal Register Proposed rule: FDA extends the comment period to 2/5/10 on a request for comments on current good manufacturing p...

ICH Draft Guidance on Studies of Geriatric Populations

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Federal Register Notice: FDA releases an ICH draft guidance, E7 Studies in Support of Special Populations: Geriatrics, Questions &...

Patient Drug Requests Dont Match Ad Spends

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Verilogue says its research shows that few ad campaigns result in many patient references to the advertised drugs in doctor visits...

Quality System Problems Found at Gibson Laboratories

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FDAs Cincinnati District Office warns Gibson Laboratories of Quality System and Medical Device Reporting violations in its manufac...

Hospira Recalls Some Liposyn and Propofol Products

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Hospira recalls specific lots of Liposyn and proprofol because some containers may contain particulate matter.

FDA Accepts NDA for ChemGenex Leukemia Drug

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FDA accepts for review a ChemGenex Pharmaceuticals NDA for Omapro (omacetaxine mepesuccinate), indicated for treating patients wit...

Edwards Catheter Recall is Class 1

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CDRH designates an Edwards Lifesciences recall of CardioVations EndoClamp Aortic Catheters as a Class 1 recall.

FDA OKs Mylans Generic Prevacid

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FDA approves a Mylan subsidiary Matrix Laboratories ANDA for a generic copy of Tap Pharmaceuticals' proton pump inhibitor Prevacid...