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Federal Food Drug and Cosmetic Act (FFDCA) 21st Century Cures Initiative

Mintz - Health Care Viewpoints

21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence

As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support...more

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