SINGLE TRIALS WITH SIZE, POWERFUL STATISTICS OR CORROBATING ENDPOINTS MAY BE CONSIDERED AS SUPPORT FOR NDAs, FDA EXPLAINS IN EFFICACY EVIDENCE GUIDANCE
Executive Summary
FDA will look more favorably on a single study as adequate support for an NDA if the study includes "several important, prospectively identified primary or secondary endpoints, each of which represents a beneficial, but different, effect," the agency explains in a draft guidance on evidence of efficacy standards released for public comment on March 13.