1. 1. U.S. Congress. Pediatric research equity act of 2003. Public Law, 108155. https://www.congress.gov/108/plaws/publ155/PLAW-108publ155.pdf (accessed September 18, 2021).
2. 2. U.S. Congress. Best Pharmaceuticals For Children Act. Public Law, 107109. https://www.congress.gov/107/plaws/publ109/PLAW-107publ109.pdf (accessed September 18, 2021).
3. 3. Hoon D, Taylor MT, Kapadia P, Gerhard T, Strom BL, Horton DB. Trends in off-label drug use in ambulatory settings: 2006-2015. Pediatrics. 2019; 144:e20190896.
4. 4. Genetic and Rare Diseases (GARD) Information Center. FAQs about rare diseases. https://rarediseases.info.nih.gov/diseases/pages/31/fags-about-rare-diseases (accessed June 20, 2021).
5. 5. U.S. Congress. Orphan Drug Act. Public Law, 97144. https://www.fda.gov/media/99546/download (accessed September 18, 2021).