Avandia's TIDE May Come In Smaller
This article was originally published in The Pink Sheet Daily
Executive SummaryTwo 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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Two advisory panels will revisit the question of whether FDA should withdraw GlaxoSmithKline’s Avandia from the market as a reevaluation of the cardiovascular trial produces results similar to the original findings; the data does not seem to offer much more clarity, but does give the agency a chance to argue it handled previous controversies well.