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Vesanoid Not Withdrawn for Safety/Efficacy Reasons

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Federal Register notice: FDA determines that Vesanoid (tretinoin) capsules 10 mg were not withdrawn from sale for reasons of safet...

Upcoming Neurolgical Devices Panel Meeting on Depression

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Federal Register notice: Advisory committee meeting 10/8 Neurological Devices Panel of the Medical Devices Advisory Committee pla...

CGMP Violations Found at BMS Puerto Rico Facility

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FDAs San Juan District Office warns Bristol-Myers Squibb over continuing CGMP issues at its Manati, Puerto Rico, drug manufacturin...

FDA Getting Tougher, Faster in Drug Inspections

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FDA deputy director of regional operations Michael Rogers warns drug makers about a tougher enforcement posture with swifter regul...

Fee Rates for Tropical Disease Vouchers

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Federal Register notice: FDA announces fee rates for using a tropical disease priority review voucher for fiscal year 2011.

Sanofi-Pasteur sBLA for Fluzone Intradermal

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Sanofi Pasteur files a supplemental BLA for Fluzone Intradermal (influenza virus vaccine).

Forest Responds to FDA Rejection Letter

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Forest Laboratories replies to a 5/17 FDA complete response letter on its NDA for roflumilast, indicated for reducing chronic obst...

FDA Issues Hepatitis C Agent Guidance

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FDA issues a draft guidance on developing direct-action antiviral agents for treating chronic hepatitis C.

FDA Approves SPA for Sapacitabine Trial

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FDA and Cyclacel agree on a Special Protocol Assessment for a Phase 3 trial of the companys sapacitabine in elderly patients with ...

Aftermath of Koran-burning Threat Could Burn FDA

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FDA Matters commentator Steven Grossman says the global alarm created by a single individuals threat to burn the Koran presents an...