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FDA’s Framework for Real-World Evidence Published!

It's here!  The long awaited FDA “draft framework for implementation” of the real world evidence program required by Section 3022 of The 21st Century Cures Act (Cures Act) has been published. Framework for FDA's Real World Evidence Program The Cures Act is designed to...

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FDA – Regulatory Considerations for Study Designs Using RWD

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them. Among other provisions, the Cures Act...

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