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# RWD Regulatory Decision Guidance
- URL: https://www.fdaweb.com/rwd-regulatory-decision-guidance/
- Published: 2021-12-09T12:00:00.000Z
- Updated: 2026-09-14T17:25:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150737

FDA has published a draft guidance, *Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products*, as part of its mandate under the 21st Century Cures Act. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug?utm%5Fmedium=email&utm%5Fsource=govdelivery) discusses the applicability of the agency’s IND regulations to various clinical study designs that use real-world data (RWD).

FDA says the guidance also clarifies the agency’s expectations concerning clinical studies using RWD submitted to support a regulatory decision on the effectiveness and safety of a drug as part of an NDA or BLA. It focuses primarily on non-interventional clinical study designs.