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# Guide on e-Health Records to Support Submissions
- URL: https://www.fdaweb.com/guide-on-e-health-records-to-support-submissions/
- Published: 2024-07-25T12:00:00.000Z
- Updated: 2026-09-14T14:36:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157431

*Federal Register* notice: FDA is making available a final guidance entitled ‘‘Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” The document 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 for effectiveness or safety. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-07-25/pdf/2024-16338.pdf?ref=fdaweb.com).