1. FDA post-marketing requirements and commitments: introduction. US Food and Drug Administration https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments. Accessed 14 Feb 2024.
2. Pediatric Research Equity Act. US Food and Drug Administration https://www.fda.gov/drugs/development-resources/pediatric-research-equity-act-prea. Accessed 14 Feb 2024.
3. Human regulatory: post-authorisation safety studies. European Medicines Agency https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-safety-studies-pass. Accessed 14 Feb 2024.
4. Human regulatory: post-authorisation efficacy studies. European Medicines Agency https://www.ema.europa.eu/en/pharmacovigilance-post-authorisation/post-authorisation-efficacy-studies-questions-and-answers. Accessed 14 Feb 2024.
5. McKinley L, Pressler ML, Hiatt MA, Gregory W. A sponsor’s view on postmarketing regulatory commitments involving human drug products. Clin Pharmacol Ther. 2022 Jun;111(6):1199–201.