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Pataday Rebate Card Not Appropriate Reminder Ad: FDA

[ Price : $8.95]

CDERs Office of Prescription Drug Promotion says that an Alcon Pataday rebate card fails to meet requirements for reminder adverti...

Tarsa Therapeutics Plans Osteoporosis NDA

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Tarsa Therapeutics says it will file an NDA in the second half of 2012 for Ostora (recombinant salmon calcitonin), an oral tablet ...

FDA OKs Scanner for Detecting Skull Bleeding

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FDA approves an InfraScan de novo petition permitting the marketing of its hand-held Infrascanner Model 1000 device, intended to a...

FDA Denies Plan B Petition Again

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FDA again denies a 2006 citizen petition from the Center for Reproductive Rights that seeks over-the-counter (OTC) status for the...

Pace Tech Warned About Quality, MDR Issues

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FDAs Florida District Office warns Pace Tech about Quality System and Medical Device Reporting violations in its manufacturing of ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Galloway Technologies, 5 Surgery Centers marketing the Lap Band, and Pace Tech.

Vertex, Alios Open Hepatitis C trials

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Vertex and Alios say they are starting Phase 1 trials of two nucleotide analogs to determine their safety and tolerability for pot...

FDA Identifies Shortcomings in Onyx NDA for Carfilzomib

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FDA says it has potential review concerns after assigning a 12-month standard review for an Onyx Pharmaceuticals NDA for carfilzom...

FDA Approves Crush-resistant Opana ER

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FDA approves a crush-resistant formulation of Endo Pharmaceuticals pain drug Opana ER (oxymorphone).

FDA Clears Meridian Bio Group B Strep Test

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FDA clears a Meridian Bioscience 510(k) for a new molecular diagnostic test for Group B Streptococcus on its illumigene platform.