Federal Public Policy Briefing: Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review
Federal Public Policy Briefing: Understanding 21 CFR 50.54: When FDA-Regulated Pediatric Research Requires Federal Review
May 27 @ 1:00 pm – 2:00 pm
Research involving children that poses more than minor increase over minimal risk without direct benefit requires federal review under 21 CFR 50.54/46.407, yet sponsors, investigators, and IRBs frequently hesitate to pursue this pathway. This session examines why that hesitancy persists, the regulatory challenges it creates, and how stakeholders can better navigate federal referral to advance pediatric research while maintaining participant protections.