1. Statement from FDA Commissioner Scott Gottlieb MD, on FDA's new strategic framework to advance use of real-world evidence to support development of drugs and biologics. Available at: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-fdas-new-strategic-framework-advance-use-real-world. Access date is 25th July, 2022.
2. When and how can real world data analyses substitute for randomized controlled trials?;Franklin;Clin Pharmacol Ther,2017
3. The new fda real-world evidence program to support development of drugs and biologics;Klonoff;J Diabetes Sci Technol,2020
4. Barriers and opportunities for use of patient registries in medicines regulation;Olmo;Clin Pharmacol Ther,2019
5. Available at: https://www.ema.europa.eu/en/guideline-registry-based-studies. Access date is 25th July, 2022.