Glossary Term

Real-World Evidence (RWE)

Study Design

Also known as: RWE, real world evidence, real-world data, RWD

Clinical evidence about the use, benefits, or risks of a medical product derived from analysis of real-world data sources such as EHRs and claims.

FDA's RWE framework (mandated by the 21st Century Cures Act) outlines how real-world data and evidence can support regulatory decisions, including new indications and post-approval requirements.

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