FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

CDER Prioritizes Real-World Evidence Framework

March 25, 2019
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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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