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Reality Check: FDA Draft Guidance Outlines Considerations for the Use of Real-World Data ...

Retrieved on: 2021-12-17 17:55:29

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Reality Check: FDA Draft Guidance Outlines Considerations for the Use of Real-World Data .... View article details on HISWAI: https://www.jdsupra.com/legalnews/reality-check-fda-draft-guidance-1981315/

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... study protocol and statistical analysis plan were finalized prior to reviewing outcome data and before performing prespecified analyses.

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