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FDA RWD/RWE regulatory considerations in draft guidance highlight opportunities and challenges - Laying groundwork for high-quality evidence to support regulatory decisions | Hogan Lovells
This month, FDA released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence (RWE) in clinical trial designs.
United states
Robert califf
Stephen hahn
Hogan lovells
Scott gottlieb
Commissioners stephen hahn
Century cures act
Cures act
Biological product submissions
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Assessing registries
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Biological products
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