1. 21st Century Cures Act. H.R. 34, 114th Congress. 2016. https://www.gpo.gov/fdsys/pkg/BILLS-114hr34enr/pdf/BILLS-114hr34enr.pdf.
2. FDA. Considerations for the Use of Real-World Data and RealWorld Evidence to Support Regulatory Decision-Making for Drug and Biological Products 2021. Available from: https://www.fda.gov/media/154714/download
3. FDA. Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry 2021. Available from: https://www.fda.gov/media/154449/download.
4. FDA. Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision Making for Drug and Biological Products 2021. Available from: https://www.fda.gov/media/152503/download.
5. FDA. Data Standards for Drug and Biological Product Submissions Containing Real-World Data 2021. Available from: https://www.fda.gov/media/153341/download.