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FDA Sets User Fee Goal for Salix Irritable Bowel Drug

[ Price : $8.95]

FDA assigns a user fee goal date for Salix Pharmaceuticals sNDA for Xifaxan for treating irritable bowel syndrome with diarrhea.

FDA Awards Critical Path Institute $2.1 Mil

[ Price : $8.95]

FDA awards the Critical Path Institute a second five-year grant that could total $10.5 million.

Congress Should Redefine Drug, Device: Attorney

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Attorney Suzanne OShea says Congress needs to clarify its intent so FDA knows how to classify combination products for review eith...

CDRH-backed Single Audit Program Up and Running

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CDRH associate director for international affairs Kimberly A. Trautman says an FDA-backed medical device single audit program shou...

White House Antibotic Resistance Report Out

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President Obamas science and technology advisors release a report and strategy on combating antibiotic resistance.

FDA Clears da Vinci Systems in Tongue Resection

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FDA clears an Intuitive Surgical 510(k) for its da Vinci S and da VinciSi Surgical Systems and their use in benign, base-of-tongue...

FDA Approves Eli Lillys New Diabetes Drug

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FDA approves an Eli Lilly NDA for Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control in adu...

FDA Urged to Act on Ranbaxy Nexium ANDA

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Consumer advocates say FDA should either find that a Ranbaxy ANDA for generic Nexium is ready for immediate approval and market en...

FDA Panel Votes Down Clarus Therapeutics Rextoro

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A joint FDA advisory committee panel votes 18-3 that the overall benefit/risk profile of Rextoro (testosterone undecanoate) was no...

FDA Proposes Salivary System into Class 2

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Federal Register Proposed order: FDA proposes to reclassify salivary stimulatory system into Class 2.