When Worlds Collide: The Theory of Real-World Evidence Meets Reality
FDA Law Blog
MAY 13, 2024
RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.
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