> ## 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.

# Real-World Data Draft Guidance
- URL: https://www.fdaweb.com/real-world-data-draft-guidance/
- Published: 2021-10-01T12:00:00.000Z
- Updated: 2026-09-14T17:17:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150272

*Federal Register* notice: FDA has made available a draft guidance entitled *Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products*. The document is intended to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records or medical claims data in clinical studies to support a regulatory decision involving product effectiveness or safety. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-09-30/pdf/2021-21315.pdf?ref=fdaweb.com).