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FDA Demands Market Withdrawal for Old Pain Drug

[ Price : $8.95]

At FDA's request, Xanodyne Pharmaceuticals agrees to withdraw its propoxyphene pain drugs Darvon and Darvocet after new clinical d...

Ethicon Files BLA for Fibrin Pad

[ Price : $8.95]

Ethicon submits a BLA to FDA for the Fibrin Pad to aid in stopping soft tissue bleeding during surgery.

FDA Warns About Viagra-containing Supplement

[ Price : $8.95]

FDA says Piston Corp.'s dietary supplement Vigor-25 illegally contains sildenafil, the active ingredient in Pfizer's Viagra.

IoM Summary on 510(k) Workshop

[ Price : $8.95]

The Institute of Medicine posts a summary of a workshop held 7/28 as part of a FDA-requested assessment of the 510(k) process.

Judge Dismisses Unapproved Morphine Suit

[ Price : $8.95]

Wyoming federal judge Alan Johnson says FDAs actions in warning companies to stop manufacturing unapproved morphine sulfate soluti...

FDA Needs Tools for Clinicians to Decipher Boxed Warnings: Researchers

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Researchers say FDA may need to provide decision-making tools to help healthcare professionals decide how a new warning on an exis...

FDA Device Delays Costly to Patients: Study

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Medical device entrepreneur Josh Makower says a survey of 200 medical device firms shows that FDA regulatory delays and inefficien...

FDA Clears Noninvasive Cardiovascular Monitor

[ Price : $8.95]

FDA clears Bmeyes ccNexfin noninvasive cardiovascular monitor with blood pressure, cardiac output, and Masimo rainbow SET pulse co...

FDA Approves Nexterone Premixed IV Bag

[ Price : $8.95]

FDA approves a Prism Pharmaceuticals supplemental NDA for Nexterone (amiodarone HCl) Premixed Injection.

Split Vote on Device for Detecting Melanoma

[ Price : $8.95]

FDA's General and Plastic Surgery Devices Panel votes 8 to 7 that benefits outweighed risks for Mela Sciences PMA for MelaFind, in...