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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...

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ICH Draft Guidance on Studies of Geriatric Populations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Federal Register Notice: FDA releases an ICH draft guidance, E7 Studies in Support of Special Populations: Geriatrics, Questions &...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

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...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites 14 tobacco product manufacturers, Gibson Laboratories and Platinum Strategies.

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...