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# Non-Interventional Studies Guidance
- URL: https://www.fdaweb.com/non-interventional-studies-guidance/
- Published: 2024-03-20T12:00:00.000Z
- Updated: 2026-09-14T14:25:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156596

FDA has published a draft guidance, *Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products*, with recommendations for sponsors and investigators who are considering submitting a non-interventional study to the agency to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of the safety of a drug. The [document](https://www.fda.gov/media/177128/download?ref=fdaweb.com) specifically discusses attributes regarding the design and analysis of a non-interventional study that sponsors should consider when proposing a non-interventional study for such regulatory purposes.

“The reliability and relevance of real-world data used in a non-interventional study are critical for making appropriate causal inferences and are essential to establishing the data’s fitness for use in generating real-world evidence to support a labeling change or address a safety concern,” the guidance says.