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21st Century Cures Act & Real World Evidence: Device Policy as Foundation

Bethany Hills and Benjamin Zegarelli co-author this piece reviewing the 21st Century Cures Act that requires the Food & Drug Administration to develop a framework and guidance for evaluating real-world evidence in the context of drug regulation and predicting on how the FDA will implement the policy. Bethany is the Chair of Mintz’s FDA practice and Benjamin’s practice focuses on FDA regulatory counseling.

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