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# RWD in Regulatory Decisions Guidance
- URL: https://www.fdaweb.com/rwd-in-regulatory-decisions-guidance/
- Published: 2024-07-24T12:00:00.000Z
- Updated: 2026-09-14T14:36:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157422

FDA has published a guidance, *Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drugs and Biological Products*, as part of the agency’s real-world evidence program under the 21st Century Cures Act. The [document](https://www.fda.gov/media/152503/download?ref=fdaweb.com) is intended to provide sponsors and other interested parties with considerations when proposing to use electronic health records or medical claims data in clinical studies to support a regulatory decision on the effectiveness or safety of a drug.

The guidance discusses these topics:

- selection of data sources that appropriately address the study question and sufficiently characterize study populations, exposure(s), outcome(s) of interest, and key covariates;
- development and validation of definitions for study design elements; and
- data traceability and quality during data accrual, data curation, and incorporation into the final study-specific dataset.

The guidance does not have recommendations on the choice of study design or type of statistical analysis, and it does not endorse any type of data source or study methodology.