FDA Releases Final Guidance on Considerations for the Use of Real-World Data and Real-World Evidence

The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties.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 This RWD/RWE Guidance finalizes the draft guidance of the same name…
By: Latham & Watkins LLP