# Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/collection-of-race-and-ethnicity-data-in-clinical-trials-and-clinical-studies-for-fda-regulated-medical-products/bb445da4-30af-4d88-b3c5-a289c2f74d92

> FDA guidance document: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. Issue date: January 30, 2024. Get complete insights and analysis.

---

## Details

- Title: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2024-01-30
- Comment Close Date: 2024-04-29
- Last Changed: 2025-02-03
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-3561">FDA-2016-D-3561</a>

## Related Documents

- [Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products](https://www.globalkeysolutions.net/guidances/guidance-document/real-world-evidence-considerations-regarding-non-interventional-studies-for-drug-and-biological-products/48325e39-b445-4a53-8cc0-7483dcf3e352)
- [Use of Data Monitoring Committees in Clinical Trials](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-data-monitoring-committees-in-clinical-trials/9d0ee35d-4fcc-4c44-88ac-f56c6a60187b)
- [Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-design-and-conduct-of-externally-controlled-trials-for-drug-and-biological-products/9dafe0c9-19d4-48c0-a1ca-6b2a04a813ed)