> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Real-World Data Use in Submissions
- URL: https://www.fdaweb.com/guide-on-real-world-data-use-in-submissions/
- Published: 2021-12-09T12:00:00.000Z
- Updated: 2026-09-14T17:25:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150735

*Federal Register* notice: FDA has made available a draft guidance entitled *Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products*. Comments on the document are being accepted until 3/9/2022\. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-12-09/pdf/2021-26640.pdf?ref=fdaweb.com).