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FDA Releases Draft Guidance on Real-World Evidence (RWE) in Clinical Trials

Posted By:  CITI Program Staff January 4, 2022

On December 9, 2021, the U.S. Food and Drug Administration (FDA) released draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” The guidance discusses expectations for FDA submissions when supporting studies use RWD.

On the guidance page you can submit a formal comment through March 9, 2022. You can also download a PDF version of the guidance.


 

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Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability View Draft Guidance