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FluLaval BLA Supplement Approved

[ Price : $8.95]

FDA approves an sBLA for a GlaxoSmithKline 2009 H1N1 pandemic influenza A vaccine for use in adults.

FDA Trying to Preempt Drug Risks: ParagonRx

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ParagonRx chief medical officer Gary Slatko says that FDA has extended its risk management activities into areas that had been sol...

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...

FDA Clears Medeor Matrix

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FDA clears Kensey Nashs Medeor Matrix for use in general surgery to reinforce and repair soft tissue.

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.

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...

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...