Pediatric Ethics Subcommittee
Executive Summary
Protocol for National Heart Blood & Lung Institute-sponsored study of surfactant synthesis in newborns will be evaluated by FDA's Pediatric Ethics Subcommittee on June 28. The protocol was rejected by the Washington University institutional review board because there would be no direct benefit to the pediatric patients involved in the study of surfactant precursors. The meeting will be held in the CDER advisory committee conference room at 5630 Fishers Lane in Rockville, Md. beginning at 8:30 a.m...