FDA discusses RWD, RWE with industry, academia
Industry, academia and FDA officials gathered Friday in Bethesda, MD to discuss the use of real-world data (RWD) and real-world evidence (RWE) in the premarket and postmarket settings.
Jacqueline Corrigan-Curay, director of CDER’s Office of Medical Policy, kicked off the joint FDA-American Association for Cancer Research meeting to discuss the FDA’s framework for using RWE, which was unveiled in December 2018. The framework is meant to guide the FDA on evaluating the potential use of RWE to support changes to labeling, including adding or modifying an indication or adding comparative effectiveness or safety information.
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