FDA Approval of Orphan Drug Indications for Pediatric Patients, 2011-2023

Affiliations

• ¹ John Sealy School of Medicine, University of Texas Medical Branch, Galveston.
• ² Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
• ³ Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts.
• ⁴ Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.
• ⁵ Pediatric Therapeutics and Regulatory Science Initiative, Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts.