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.”
After presentation of an overview of the IRB referral process under 21 CFR 50.54, an overview of the protocol and the issues raised by the IRB referral, other relevant presentations about the request to modify the protocol, and a summary of the public comments received concerning whether the protocol should proceed as modified, the committee will discuss the protocol modification and develop a recommendation regarding whether the protocol should proceed as modified. The committee's recommendation will then be presented to the Commissioner of Food and Drugs.
More information, including information about submitting comments, is available via the Federal Register notice.