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Ban Commercial CME Support: Public Citizen

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Public Citizen says it supports an Accreditation Council for Continuing Medical Education proposal to end commercial support of CM...

Animal Drug User Fees Out

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FDA publishes FY 2009 animal drug and generic animal drug user fee rates.

Complete Response on Fentora Indication

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FDA gives Cephalon a complete response letter to its sNDA for an expanded Fentora indication for non-cancer breakthrough pain.

Davanat NDA Data Submitted to FDA

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Pro-Pharmaceuticals submits Davanat clinical and manufacturing data to FDA to support its NDA for the colorectal cancer treatment.

FDA Approves Nausea Patch

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FDA approves ProStrakans Sancuso patch to control nausea and vomiting in chemotherapy patients.

Enforcement Actions Decline at CDRH

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CDRH director Daniel Schultz presents enforcement data at an industry meeting showing a decline in actions this fiscal year.

FDA Approves Fougera ANDA for Generic Clotrimazole

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FDA approves a Fougera ANDA for a generic copy of Taros referenced listed product clotrimazole.

FDA Staffing Up 1,300

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FDA says it has hired more than 1,300 new staffers, with half of them going to CDER.

New Chantix Ad is 50% Risk Info

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Forbes magazine says a new 90-second TV spot for Pfizers anti-smoking drug Chantix includes 41 seconds of risk information.

Drug Label Preemption Likely to be Upheld: Attorney

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Attorney Robert Bourque predicts the U.S. Supreme Court will support FDA preemption of state failure-to-warn requirements in drug ...