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Labopharms API Maker Given Passing Grade on Antidepressant

[ Price : $8.95]

Labopharm says its active pharmaceutical ingredient manufacturer referenced in a pending NDA has cleared up GMP deficiencies that ...

Sanofi-Aventis Supporting Social Marketing Diabetes Program

[ Price : $8.95]

A Sanofi-Aventis-funded program is using social media to encourage diabetes education and action.

ViroPharma Raises Generic Vancocin Approval Issues

[ Price : $8.95]

ViroPharma says FDA should follow the recommendation of its advisory committee on how to approve generic vancomycin capsules.

Emergency Use Products Info Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on emergency use authorization of medical products to th...

Joint Panel to Discuss Contrast Agents

[ Price : $8.95]

Federal Register Notice: FDA Cardiovascular and Renal Drugs and the Drug Safety and Risk Management Advisory Committees will meet ...

FDA Clears BD Rapid Blood Collection Device

[ Price : $8.95]

FDA clears a BD Diagnostics - Preanalytical Systems 510(k) for the BD Vacutainer Rapid Serum Tube.

FDA Complete Response on Genzymes Clolar

[ Price : $8.95]

FDA issues Genzyme a complete response letter on its sNDA for Clolar (clofarabine) and its use in previously untreated older adult...

Philips Recalls Some HeartStart AEDs

[ Price : $8.95]

Philips recalls 5,400 automated external defibrillators that may have a defective memory chip that could render them inoperable.

Pediatric Panel to Discuss Safety Reviews

[ Price : $8.95]

Federal Register Notice: FDAs Pediatric Advisory Committee will meet 12/8 to discuss pediatric-focused safety reviews.