FDA Approval of Orphan Drug Indications for Pediatric Patients, 2011-2023
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DOI: 10.1001/jamapediatrics.2024.5280
Abstract: This cohort study assesses Pediatric Research Equity Act amendments that may influence approval of orphan drug indications for pediatric patients under current regulatory programs. read more here.
Keywords: approval orphan; pediatric patients; indications pediatric; drug indications ... See more keywords