Avandia Safety Rhetoric Ramps Up Ahead Of Advisory Committee Review
Executive Summary
Participants in the ongoing safety debate over GlaxoSmithKline's Avandia (rosiglitazone) are refining their arguments ahead of the July 13-14 joint FDA advisory committee meeting on the troubled thiazolidinedione's future
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Anatomy Of The Avandia Decision: FDA’s Woodcock Splits The Difference Between OND, OSE Views
In deciding to keep GlaxoSmithKline PLC’s Avandia on the market, while also heavily restricting its use, FDA Center for Drug Evaluation and Research Director Janet Woodcock split the difference between opposing recommendations from the Office of New Drugs and Office of Surveillance and Epidemiology.