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No Injunction in Generic Prilosec Case

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A judge says FDA had no choice but to convert its approval of an Apotex ANDA for generic Prilosec from final to tentative after an...

FDA Beefing Up its External Communications Efforts

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FDA regulatory policy director Jarilyn DuPont describes a comprehensive effort to improve agency communications with consumer, pro...

FDA Launches Drug Safety Newsletter

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FDA publishes the first issue of its new quarterly online Drug Safety Newsletter, focusing on Genentechs Rituxan, Cephalons Provig...

Quality Problems Found at Danmar Plant

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FDAs Detroit District Office warns Danmar Products about Quality System and device listing violations.

FDA Clears Varian Medical Collimator

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FDA grants 510(k) clearance to Varian Medical Systems for its HD120 MLC high-definition multileaf collimator, an ultra-fine beam s...

FDA Accepts Sucampo sNDA for IBS

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FDA accepts a Sucampo Pharmaceuticals sNDA for lubiprostone for treating irritable bowel syndrome with constipation.

FDA Clears Blood Platelet Contamination Test

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FDA clears Verax Biomedicas Platelet Pan Genera Detection Test for use in hospital transfusion services.

Grassley Urges FDA Reforms in Conference Committee

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Sen. Chuck Grassley calls on House and Senate conferees to report a strong FDA reform bill that emphasizes drug safety.

Latest FDA Warning Letters

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In todays batch of Warning Letters, FDA cites Danmar Products, Pamela Grady, North Coast Medical, Procter and Gamble, and William ...

FDA Says P&G Sanitizer is Unapproved New Drug

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FDA warns P&G over marketing for its Early Defense hand sanitizer that makes it an unapproved new drug.