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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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.
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