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# Real-World Data Guidance on Using Registries
- URL: https://www.fdaweb.com/real-world-data-guidance-on-using-registries-2/
- Published: 2021-11-30T12:00:00.000Z
- Updated: 2026-09-14T17:23:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150661

*Federal Register* notice: FDA is making available a draft guidance on *Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products*. The document provides sponsors with considerations about designing a registry or proposing to use an existing registry to support a regulatory decision about a drug’s effectiveness or safety. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-30/pdf/2021-26006.pdf?ref=fdaweb.com).