Avandia's TIDE May Come In Smaller
This article was originally published in The Pink Sheet Daily
Executive Summary
Two advisory panels recommended that FDA allow the trial of GlaxoSmithKline's Avandia (rosiglitazone) to continue but questioned its design, providing important hints for drug companies planning post-marketing safety trials in the future.
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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.