Avandia Concerns Highlight Need To Change Diabetes Approval Standards
Executive Summary
FDA should forgo use of glycemic control as a surrogate endpoint for clinical trials supporting the approval of type 2 diabetes therapies, Clifford Rosen said following the advisory committee review of GlaxoSmithKline's Avandia
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Sponsors of new type 2 diabetes therapies should be required to provide clinical data that can exclude an unacceptable cardiovascular risk prior to approval, FDA's Endocrinologic and Metabolic Drugs Advisory Committee concluded at a July 1-2 meeting