On December 9, 2021, the U.S. Food and Drug Administration (FDA) released draft guidance entitled “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.”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.
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Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability
View Draft Guidance
