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FDA OKs Cephalons New Cancer Pain Drug

[ Price : $8.95]

FDA approves a Cephalon NDA for its breakthrough pain drug Fentora.

FDA OKs Cordis Carotid Stent System

[ Price : $8.95]

After resolving quality issues at its manufacturing facilities, Cordis Endovascular wins final FDA approval on a PMA for the Preci...

FDA Guidance on Keratome 510(k) Submissions

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FDA releases a new guidance to assist industry in preparing 510(k) submissions for keratomes and replacement keratome blades.

IoM Wants New Drug DTC Moratorium

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The Institute of Medicine report on drug safety calls for a two-year moratorium on advertising of new drugs.

FDA Amends Regs for Single Use Devices

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Federal Register Proposed and direct final rules: FDA amends certain classification regulations for reprocessed single-use devices...

Review Period Set for Genzymes Clolar

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Federal Register Notice: FDA determines the regulatory review period for patent extension for Genzymes Clolar.

FDA Clears Medtronic Aspiration Catheter

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FDA clears a Medtronic 510(k) for its Export XT Aspiration Catheter to remove dangerous embolic materials.

Epix Drug Fails on GAD, But Promising for Depression

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Epix Pharmaceuticals says trial data involving its investigational antidepressant PRX-00023 were not favorable for a general anxie...

Generic Plavix Oral Arguments Set for 10/31

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After an appeals court rejects Apotexs bid to stay a preliminary injunction, oral arguments are now set for 10/31 in Sanofi-Aventi...

FDA OKs New Lamictal Epilepsy Indication

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FDA approves a fifth epilepsy indication for GlaxoSmithKlines Lamictaltreating grand mal seizures in children and adults.