Home » CDER Prioritizes Real-World Evidence Framework
CDER Prioritizes Real-World Evidence Framework
March 22, 2019
Using real-world evidence “remains a top priority” at the FDA, said Jacqueline Corrigan-Curay, director of CDER’s Office of Medical Policy, in a March 15 webinar to review the agency’s recently issued framework for using real-world evidence and data in postmarket scenarios.
The agency plans to develop a pathway that makes RWE-based solutions a full-time part of the drug regulatory process, she said.
The FDA wants to evaluate RWE’s potential to support labeling changes, such as adding a new population, comparative effectiveness, indication or safety information, or modifying an existing indication.
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