FDA clarification of efficacy requirements falls short of "Re-Go" objectives, PhRMA tells agency.
Executive Summary
FDA CLARIFICATION OF EFFICACY REQUIREMENTS FALLS SHORT OF "RE-GO," PhRMA maintains in Oct. 27 comments on the agency's statement regarding demonstrations of drug effectiveness in the Aug. 1 Federal Register. The Pharmaceutical Research & Manufacturers of America maintained that the notice is a statement of "criteria that are already well known concerning studies of comparative effectiveness and study replication including the number of studies required by the FDA to demonstrate effectiveness for a new indication of a particular pharmaceutical product."