When Worlds Collide: The Theory of Real-World Evidence Meets Reality
The FDA Law Blog
MAY 13, 2024
Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.
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