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# Draft Guide on Real World Data Submissions
- URL: https://www.fdaweb.com/draft-guide-on-real-world-data-submissions/
- Published: 2019-05-09T12:00:00.000Z
- Updated: 2026-09-15T01:25:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144069

*Federal Register* notice: FDA has made available a draft guidance entitled “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.” The document provides instructions on how to document that a submission includes real-world evidence. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-09/pdf/2019-09529.pdf?ref=fdaweb.com).