FDA Eases Access to Real-World Evidence in Drug and Device Reviews

The Food and Drug Administration announced Monday that it will remove a major barrier to using real-world evidence (RWE) in drug and device application reviews. The agency will now accept RWE without requiring that identifiable individual patient data from real-world sources always be submitted in marketing applications. FDA is also considering similar updates for drugs and biologics.

Previously, the agency required that all submitted RWE include confidential, individual-level patient information, which made it impractical to use large databases containing macro-level insights. Under the new approach, FDA reviewers will evaluate RWE on a case-by-case basis, allowing sponsors to leverage de-identified datasets to support regulatory submissions.