U.S. Food and Drug Administration.
URL: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
Abstract. Framework describing how FDA evaluates use of real-world data to support regulatory decisions, fundamental for RWE in healthcare. The FDA has published multiple guidance updates through 2024-2025 expanding on RWE/RWD use, including guidance on registries, electronic health records as data sources, and fit-for-purpose data standards.