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Anatomy Of The Avandia Decision: FDA’s Woodcock Splits The Difference Between OND, OSE Views

Executive Summary

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.

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