The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Pediatric Ethics Subcommittee (PES). The general function of the committees is to provide advice and make recommendations to the Agency on pediatric ethical issues.
The PAC and the PES will meet to discuss a referral by an Institutional Review Board (IRB) of a clinical investigation that involves children and FDA regulated products. The clinical investigation is entitled “A Double-Blind, Placebo-Controlled, Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.” Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
More information, including information about attending the joint meeting of the PAC and PES, is available via the Federal Register notice.