On Friday May 11, 2018 the Pediatric Advisory Committee (PEDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met jointly to discuss drug development for the treatment of children with achondroplasia. The following topics were discussed: evidence required to establish dose-response, study design, study duration, intended population, and endpoints.
From 8:00 am to 11:00 am, the meeting was closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the Committees discussed the premarketing drug development program of an investigational product.
Originally, this meeting was scheduled for March 22, 2018, but it was postponed due to inclement weather.