Mitre
Executive Summary
Company officials discuss status of FDA external review contract with CDER Deputy Director Gerald Meyer at June 16 meeting. FDA is being asked by the Bedford, Mass.-company about the continuation of the external review project after the expected increase in FDA's internal review capacity from user fee funding. Mitre has completed review of two efficacy supplements for the agency and is working on a third under a $221,608 contract signed Sept. 24, 1992.