Federal Register #2026-22996

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

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.

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