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FDA Issues 'Reminder' on Plavix Concomitant Use with Omeprazole

[ Price : $8.95]

FDA issues a reminder against Plavix's concomitant use with omeprazole because the co-administration can result in significant red...

Watson Files 505(b)(2) NDA for Salt Version of Crestor

[ Price : $8.95]

Watson Pharmaceuticals files a 505(b)(2) NDA to market rosuvastatin zinc (5, 10, 20 and 40 mg tablets), a new salt version of Astr...

Comments Sought on Device Fellowship Program Application

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on the application for the Medical Device Fellowship Program.

OMB OKs Info on Emergency Use Authorization of Medical Products

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on a draft guidance on emergency...

OMB OKs Info on Mammography Quality Standards Act

[ Price : $8.95]

Federal Register Notice: The Office of Management and Budget approves a collection of information on the Mammography Quality Stand...

FDA Clears AutoGenomics Assay

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FDA clears an AutoGenomics 510(k) to market the Infiniti CYP2C19 Assay to detect three genetic variants of the CYP450 2C19 gene.

FDA Grants AIDS Microbicide Gel Fast-Track

[ Price : $8.95]

FDA grants fast-track status to developers of a microbicide gel indicated to protect women from the AIDS virus.

Glaxo Whistleblower Receives $96 Million

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Former Glaxo employee Cheryl Eckard receives $96 million dollars as part of a whistleblower lawsuit filed against the company in 2...

Sandoz Recalls All Methotrexate Injection Lots

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Sandoz recalls of all lots of its Sandoz and Parenta brand methotrexate injection in 50mg/2mL and 250mg/10mL vials after small gla...

FDA Seizes Unapproved Drugs at Tri-Med

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U.S. marshals acting on FDA's behalf seize prescription and over-the-counter drug products from Tri-Med Laboratories in Somerset, ...