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)