1. FDA. Framework for FDA’s Real-World Evidence Program. 2018. http://www.fda.gov/media/120060/download Accessed December 5, 2019
2. Berger M, et al. A framework for regulatory use of real-world evidence. http://healthpolicy.duke.edu/sites/default/files/atoms/files/rwe_white_paper_2017.09.06.pdf Updated September 13, 2017. Accessed December 5, 2019
3. Using natural experiments to evaluate population health interventions: new Medical Research Council guidance
4. FDA. FDA’s Sentinel Initiative. http://www.fda.gov/safety/fdas-sentinel-initiative Updated October 18, 2019. Accessed December 5, 2019.
5. FDA. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. http://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program Updated December 2, 2019. Accessed December 5, 2019