# Federal Register #2026-22996

FDA Seeks Input on Patient-Level Real-World Data for Drug and Biologic Submissions

**Buyer:** Department of Health and Human Services / Food and Drug Administration
**Posted:** November 12, 2026
**Respond By:** January 12, 2027
**Identifier:** 2026-22996

The U.S. Food and Drug Administration is seeking public input on patient-level real-world data used in drug and biological product submissions.
- **Government agency:** U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), including the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
- **Purpose:** Gather perspectives on access to patient-level real-world data (RWD) used to develop real-world evidence (RWE) for regulatory submissions.
- **Topics for input:** Data-use agreements; patient-level data submission and retention; technical interoperability; independent review; and collaboration with external parties. Privacy, data stewardship, and modernization of FDA information technology are also relevant considerations.
- **Potential respondents:** Regulated industry, health information technology vendors, academic medical centers, electronic data capture vendors, patient advocates, and other interested parties. No specific OEMs or vendors are named.
- **Procurement status:** This is a request for information, not a purchase of products or services. No quantities, part numbers, contract value, or performance period are provided.

### Description

The FDA requests input on patient-level data access for real-world evidence used in regulatory decisions on drug and biological product submissions. It seeks innovative approaches to challenges submitting patient-level real-world data analyzed in clinical studies included in marketing applications. The notice invites perspectives on data-use agreements, data transfer and retention, interoperability, independent review, and collaboration with external parties. Comments are due January 11, 2027.

[View original listing](https://www.federalregister.gov/documents/2026/11/12/2026-22996/patient-level-data-for-drugs-and-biological-products-submissions-containing-real-world-data-and)