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Efficacy evidence definition from FDA expected "soon," Woodcock tells UT-Austin conference.

Executive Summary

EFFICACY EVIDENCE DEFINITION BY FDA TO EMERGE "VERY SOON," Center for Drug Evaluation & Research Director Janet Woodcock, MD, told the University of Texas International Industrial Pharmacy Conference in Austin, Tex. Feb. 24. CDER "has never been very explicit about what types of quality of evidence" are needed "to show efficacy," Woodcock said. An upcoming evidence guidance document "spells this out using a large number of examples." Woodcock said the document "will be particularly useful for supplemental indications, where there's a lot of extant evidence available and the question is how much additional evidence do you need." The evidence document "also pertains to...original NDA submissions," she added.

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