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4. FDA Guidance Document (2018): Framework for FDA’s Real-world Evidence Program, https://www.fda.gov/media/120060/download
5. FDA Guidance Document (2021): Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory.