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FDA Antiviral Drugs Advisory Committee

Executive Summary

Tentatively schedules meeting for Sept. 12-13 to discuss the use of surrogate markers and the accelerated approval process. At its May 20 gathering, a committee member suggested that a meeting be held to re-discuss accelerated approval in light of questions about the ability of surrogate markers to predict a drug's ultimate efficacy ("The Pink Sheet" May 23, T&G-1)
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