When Worlds Collide: The Theory of Real-World Evidence Meets Reality – Part II
FDA Law Blog
MAY 22, 2024
By Jeffrey N. Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — We recently blogged about the Center for Devices and Radiological Health’s (CDRH) reluctance to make full use of real-world data (RWD) and real-world evidence (RWE) to support marketing applications. In response to the post, we did receive feedback from a company that had had the good fortune to have very positive experiences with RWD/RWE.
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