1. EMA. European Medicines Agency, Guideline on Pharmaceutical Development of Medicines for Paediatric Use. EMA; London, UK: 2013. [(accessed on 2 February 2022)]. Available online: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf. 2013.
2. FDA. Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act Guidance for Industry. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Available at https://www.fda.gov/media/168201/download. 2023.
3. FDA. Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans Guidance for Industry.U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER). Available at https://www.fda.gov/media/86340/download. 2020.
4. FDA. E11 Clinical Investigation of Medicinal Products in the Pediatric Population. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Available at https://www.fda.gov/media/71355/download. 2000.
5. EC. Regulation (EC) no 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. 2006.