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Pozen Gets 2nd Complete Response Letter on Yosprala

[ Price : $8.95]

FDA issues Pozen a second complete response letter (CRL)on its NDA for Yosprala (aspirin and omeprazole) delayed release tablets, ...

FDA Clears Sorins Memo 3D ReChord Annuloplasty Ring

[ Price : $8.95]

FDA clears Sorin Groups Memo 3D ReChord annuloplasty ring for mitral valve repair.

FDA Grants Priority Status for Gastrointestinal Sealant

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FDA grants priority review for Cohera Medicals Sylys Surgical Sealant to help reduce anastomotic leakage in gastrointestinal proce...

Covis Pharma Cited for Promo Violations

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CDERs Office of Prescription Drug Promotion sends an untitled letter to Covis Pharmaceuticals over a physician letter promoting La...

FDA Hits Amarin Pharma with Promotional Violation Letter

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FDA objects to an Amarin Pharmaceuticals promotional Rapid Overview Webcast Series - Print Invitation for Vascepa (icosapent ethy...

Novo Nordisk Files NDA for Weight Management

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Novo Nordisk files an NDA with FDA for a 3 mg dose of liraglutide for chronic weight management.

Illinois Court Has Different Take on Preemption: Lawyers

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A medical device product liability lawsuit overcomes a federal preemption defense by relying on a controversial Seventh Circuit Co...

Caronia Decision Dissected in Harvard Law Review

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This months Harvard Law Review takes a look at the year-old Caronia court decision and finds that while it is defensible as a matt...

Ariad Gets FDA OK to Return Iclusig to Market

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FDA approves Ariad Pharmaceuticals plan to return its leukemia drug Iclusig (ponatinib) to the market.

FDA Employees Rank FDA Lower on Best of Survey

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FDA slips in the annual agency rankings of Best Places to Work in the Federal Government.