The Avandia Penumbra: Remapping Diabetes Drug Development
• By Mark Ratner
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.
Mark L. Ratner
The heated discussion around the use of GlaxoSmithKline PLC ’s rosiglitazone ( Avandia) has done more than raise issues of one drug’s safety. It has sent tremors through the drug...
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