1. Nebeker RJ, Barach P, Samore MH. Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. Ann Intern Med. 2004;140(10):795–801. https://doi.org/10.7326/0003-4819-140-10-200405180-00009.
2. World Health Organization. Safety of medicines: a guide to detecting and reporting adverse drug reactions; 2002. https://www.who.int/publications/i/item/WHO-EDM-QSM-2002-2. Accessed 2 May 2023.
3. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry and investigators safety reporting requirements for INDs and BA/BE studies; 2012. https://www.fda.gov/media/79394/download. Accessed 2 May 2023.
4. Hardin AP, Hackell JM, Committee on Practice & Ambulatory Medicine. Age limit of pediatrics. Pediatrics. 2017;140(3) https://doi.org/10.1542/peds.2017-2151.
5. US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Guidance for industry and FDA staff: pediatric expertise for advisory panels; 2003. https://www.fda.gov/media/72451/download. Accessed 11 May 2022.