The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties.

On August 31, 2023, the US Food and Drug Administration (FDA or the Agency) released final guidance on “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products” (the RWD/RWE Guidance). This RWD/RWE Guidance finalizes the draft guidance of the same name issued on December 9, 2021, and discusses the applicability of FDA’s investigational new drug application (IND) regulations under 21 C.F.R. Part 312 to various clinical study designs that utilize real-world data (RWD). The RWD/RWE Guidance also clarifies the Agency’s expectations concerning both real-word evidence (RWE) and clinical studies using RWD that are submitted to FDA to support regulatory decisions regarding the effectiveness and safety of drugs when such studies are not subject to Part 312.