Public Comment on  FDA Docket No. FDA-2023-D-5470: Real-World
Evidence: Considerations Regarding Non-Interventional Studies for Drug and
Biological Products; Draft Guidance for Industry – 18 June 2024

Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry; Availability
A Notice by the Food and Drug Administration on 03/21/2024
Submit comments by June 18, 2024
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.” FDA is issuing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision-making. The draft guidance provides recommendations to sponsors who are considering submitting a non-interventional study, also referred to as an observational study, to FDA to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug. This draft guidance was developed in response to stakeholders’ growing interest in the potential use of non-interventional studies to contribute to a demonstration of the effectiveness or safety of a drug.