NIH Funded Pediatric Labeling Changes for drugs studied under the 409i process

Section 409i of BPCA requires NIH and FDA to prioritize therapeutic areas in critical need of pediatric research. NICHD then facilitates clinical trials and data are submitted to FDA who determines if labeling changes are appropriate. This site lists such approved labeling changes.

Source: FDA Center for Drug Evaluation and Research - What's New - February 28, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news