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# Real-World Data Registries Guidance
- URL: https://www.fdaweb.com/real-world-data-registries-guidance/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:19:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156021

FDA has published a guidance, *Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drugs and Biological Products*, with information about **(1)** a registry’s fitness for use in regulatory decision-making, focusing on registry attributes that support the collection of relevant and reliable data, **(2)** linking a registry to another data source for supplemental information, and **(3)** supporting FDA review of submissions that include registry data. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products?ref=fdaweb.com) was issued, FDA says, as part of its real-world evidence program and to satisfy in part a mandate in the Federal Food, Drug, and Cosmetic Act on the use of real-world evidence in regulatory decision-making.