Gottlieb: FDA May Soon Accept RWE To Support Labeling Updates

By Beth Wang / November 20, 2017 at 3:15 PM
FDA is considering how real-world evidence (RWE) can be used to update product labels, and labeling may be the first area in which the agency develops a clear framework for the use of real-world evidence, agency Commissioner Scott Gottlieb told a group of stakeholders during Friends of Cancer Research's (FOCR's) annual meeting. “As we think about how do we keep product labels up-to-date, more and more we’re going to be relying on practical evidence developed in real-world clinical practice. And...

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