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FDA Clears bioMrieux Mass Spectrometry System

[ Price : $8.95]

FDA clears a bioMrieux de novo 510(k) for Vitek MS, a clinical mass spectrometry system for rapid identification of disease-causin...

Ex-CVM Director Sundloff Lands in Industry

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Former CVM director Stephen Sundlof joins Kindred Biosciences as senior vice president of regulatory affairs.

Disappointing Data on GSK Crohns Drug

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GlaxoSmithKline says data from a Phase 3 study were disappointing with its investigational Crohns disease drug verciron.

FDA Clears Zimmer Shoulder System

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FDA clears a Zimmer 510(k) for the company to market its Patient Specific Instruments Shoulder system to complement its Trabecular...

FDA Withdraws 3 NADAs

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Federal Register Final rule: FDA amends the animal drug regulations to reflect the withdrawal of two Phibro Animal Health NADAs an...

FDA Accepts Pennsaid NDA Resubmission

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FDA has accepted for review a Mallinckrodt NDA resubmission for topical pain products Pennsaid (diclofenac sodium topical solution...

Navidea Bio Secures FDA Special Protocol for Phase 3 Tremor Trial

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Navidea Biopharmaceuticals reaches agreement with FDA for two special protocol assessments for its pivotal Phase 3 program with NA...

Info On Hypertension Drug Labeling Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on a guidance on drug labeling and a hypertension indica...

FDA PMA Approval for PFM Medicals Nit-Occlud

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FDA approves a PFM Medical PMA for its Nit-Occlud PDA (patent ductus arteriosus) device.

Groups Urge Stronger U.S. Position on Banned Vet Drugs

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Three consumer advocacy organizations urge the U.S. to recommend that nine veterinary drugs that are banned in this country also b...