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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.

Company Marketing Unapproved Drug Abuse Test

[ Price : $8.95]

FDA warns American Bio Medica that it is selling an unapproved OTC drug abuse test for public use in workplaces.

FDA Clears New Boston Scientific Biliary Stents

[ Price : $8.95]

FDA clears a Boston Scientific 510(k) for the WallFlex Biliary RX fully and partially covered stents for the palliative treatment ...

List of Approved PMAs Posted

[ Price : $8.95]

Federal Register Notice: FDA publishes a list of approved PMAs.

Panel to Discuss Novartis NDA

[ Price : $8.95]

Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 12/7 to discuss Novartis NDA for everoli...

Panel to Discuss Spine System

[ Price : $8.95]

Federal Register Notice: FDAs Orthopedic and Rehabilitation Device Panel will meet 11/4 to discuss Zimmer Spines PMA for the Dynes...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites American Bio Medica, Mountain Meadow Herbs, Phoenix Medical Devices and Weartech...

Advisors Narrowly Back New Pegintron Indication

[ Price : $8.95]

FDAs Oncologic Drugs Advisory Committee votes 6-4 to recommend approval of Schering-Ploughs Pegintron as adjuvant treatment for pa...