The Avandia Penumbra: Remapping Diabetes Drug Development

The implosion of Avandia has raised several critical issues for diabetes drug developers, including whether companies can still rely on glycemic control as the primary endpoint for approval and the extent to which late-stage comparative trials conducted versus Avandia are still useful. The decisions FDA makes in the wake of Avandia will also be important milestones affecting other therapeutic categories, as they will reflect how the agency is assessing and monitoring drug safety generally.