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Polyethylene Glycol ANDAs Misbranded

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Federal Register Notice: FDA proposes to withdraw approval of five generics of MiraLax (polyethylene glycol) that are labeled for ...

Panel to Discuss Ovation Pharma NDAs

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 1/7-8/09 to discuss two Ova...

FDA Clears Boston Scientific Wallstent

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FDA clears Boston Scientifics Wallstent carotid artery stent.

Panel to Discuss B&L, Allergan NDAs

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Federal Register Notice: FDAs Dermatologic and Ophthalmic Drugs Advisory Committee will meet 12/5 to discuss a Bausch & Lomb NDA f...

Panels to Discuss Beta-2 Adrenergic Agonists

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs, Drug Safety and Risk Management, and the Pediatric Advisory Committees will...

Error Corrected on CGMP Rule

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Federal Register Final rule: FDA corrects a small error in a 9/8 final rule related to the amending certain of its regulations on ...

FDA Will Review Meda Antihistamine NDA

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FDA says it will review Medas NDA for a once-daily nasal antihistamine spray.

FDA Clears NanoVibronix PainShield

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FDA clears NanoVibronix PainShield diathermy device for treating pain.

New VinBLASTine Supply Has Shorter Shelf Life

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APP says it is releasing one lot of VinBLASTine with a reduced shelf life to help resolve a supply shortage.

CBER Meets PDUFA, MDUFMA Goals

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CBER director Jesse Goodman says the Center met or exceeded all of its review goals in FY 2007.