# Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/real-world-data-assessing-registries-to-support-regulatory-decision-making-for-drug-and-biological-products/c6608901-2ab6-4ea9-874e-5a6c2a65f9a4

> FDA guidance document: Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products. Issue date: December 22, 2023. Get complete insights and analysis.

---

## Details

- Title: Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2023-12-22
- Last Changed: 2025-02-03
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-1146">FDA-2021-D-1146</a>

## Related Documents

- [Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/real-world-data-assessing-electronic-health-records-and-medical-claims-data-to-support-regulatory-decision-making-for-drug-and-biological-products-guidance-for-industry/acb241e2-27a2-4f0c-9d67-8a9472ad939a)
- [Data Standards for Drug and Biological Product Submissions Containing Real-World Data:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/data-standards-for-drug-and-biological-product-submissions-containing-real-world-data-guidance-for-industry/7cd29686-06b7-467b-bad3-2023b48076b2)
- [Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/considerations-for-the-use-of-real-world-data-and-real-world-evidence-to-support-regulatory-decision-making-for-drug-and-biological-products-guidance-for-industry/41d12e6b-4639-4430-9ace-220364a487a1)
