Timing of Pediatric Drug Approval and Clinical Evidence Submitted to Regulatory Authorities: International Comparison Among Japan, the United States, and the European Union

Many prescription drugs approved for adult use lack pediatric labeling information, resulting in their off‐label use in children. Drug regulatory authorities have developed legal and regulatory frameworks to promote pediatric drug development. However, the current state of pediatric indication approval and quality of efficacy evidence, which forms the basis of regulatory approvals, is unknown. Here, we analyzed novel therapeutics approved in...