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GAO to report on non-inferiority trials

Executive Summary

Four Congressional Democrats and Sen. Charles Grassley (R-Iowa) have requested a Government Accountability Office report on FDA's use of non-inferiority trials. The request specifically mentions Sanofi-Aventis' antibiotic Ketek, which recently updated its label following reports of hepatoxicity and has been the subject of scrutiny from Grassley (1"The Pink Sheet" July 3, 2006, p. 7). GAO is tasked with reporting on approvals over the past decade from the Office of Antimicrobial Products based on non-inferiority trials. The request also seeks information on FDA's precautions against "bio-creep," the approval of products based on successively less effective comparator agents...
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