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# Real-World Data Standards Guidance
- URL: https://www.fdaweb.com/real-world-data-standards-guidance/
- Published: 2021-10-21T12:00:00.000Z
- Updated: 2026-09-14T17:19:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150414

FDA has published a draft guidance, *Data Standards for Drug and Biological Product Submissions Containing Real-World Data*, with recommendations for sponsors complying with provisions of the Federal Food, Drug, and Cosmetic Act when submitting real-world data (RWD) as study data in applicable drug submissions. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-drug-and-biological-product-submissions-containing-real-world-data?ref=fdaweb.com) was issued as part of the FDA real-world evidence program and to satisfy a legislative mandate in the 2016 21st Century Cures Act to issue guidance on using real-world evidence

The guidance addresses considerations for the use of data standards currently supported by FDA in applicable drug submissions concerning study data derived from RWD sources. For purposes of the guidance, the agency says it defines RWD as data relating to individual patient health status or the delivery of health care routinely collected from a variety of sources.