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FDA OKs Roche Hepatitis B Test

[ Price : $8.95]

FDA approves Roche Diagnostics Cobas TaqMan HBV Test which is intended to measure the amount of viral DNA (viral load) in hepatiti...

FDA Priority Review for GTC Biotherapeutics BLA

[ Price : $8.95]

FDA assigns a priority review for GTC Biotherapeutics BLA for Atryn, intended for use in patients with hereditary antithrombin def...

FDA OKs Edwards Lifesciences Heart Valve

[ Price : $8.95]

FDA approves an Edwards Lifesciences PMA for the Carpentier-Edwards Perimount Magna mitral heart valve.

Nonclinical Safety Studies Guidance

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance on nonclinical safety studies for the conduct of human clinical trials and ...

FDA Teaches Consumers How to Read Print Ads

[ Price : $8.95]

FDA publishes a consumer guide to prescription drug print ads, inviting reports about violative ads.

Anti-cancer Drugs Get Most Fast Track

[ Price : $8.95]

A Tufts Center for the Study of Drug Development analysis shows anti-cancer drugs have been most likely to receive fast track desi...

Committee Has More Vytorin Questions

[ Price : $8.95]

Reps. Dingell and Stupak ask Merck/Schering-Plough for more information on the Vytorin SEAS study report prepared by a British res...

Panel to Discuss Canine Cells for Influenza Vaccines

[ Price : $8.95]

Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 9/25 to discuss using Madin-Da...

FDA Reports Short Supply of Imaging Agent

[ Price : $8.95]

FDA says that Mallinckrodt is experiencing a short supply of imaging agent Ultra-TechneKow DTE (technetium Tc 99m generator) due t...

Biovail ANDA for Generic Copy of Tricor

[ Price : $8.95]

Biovail files an ANDA for fenofibrate tablets, a generic copy of Abbotts lipid-lowering Tricor.