When Worlds Collide: The Theory of Real-World Evidence Meets Reality
FDA Law Blog
MAY 13, 2024
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. RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.”
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