# 2026-22996: FDA Seeks Advice on Patient Data Behind Real-World Drug Evidence 2026-22996, Patient-Level Data for Drugs and Biological Products Submissions Containing Real-World Data and Real-World Evidence; Request for Information, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-11-12, effective Comments must be submitted by January 11, 2027 (electronic filing accepted until 11:59 p.m. Eastern Time on that date).; PRIA reads it as touching household money (as of 2026-11-12). - Canonical: https://policyrisk.com/federal-register/2026-22996 - As of: 2026-11-12 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-22996 - Title: Patient-Level Data for Drugs and Biological Products Submissions Containing Real-World Data and Real-World Evidence; Request for Information - Type: Notice - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 91 FR 72875 - Published: 2026-11-12 - Effective: Comments must be submitted by January 11, 2027 (electronic filing accepted until 11:59 p.m. Eastern Time on that date). - Comments close: 2027-01-11 - Significant: no - Touches household money: yes - Regulation identifier numbers: none - Last updated: 2026-11-12 ## In one line FDA Seeks Advice on Patient Data Behind Real-World Drug Evidence ## Summary The FDA wants your ideas on how to handle patient-level data when using real-world evidence for drug and biological product approvals. This affects drug makers, tech vendors, researchers, and patient groups who submit or use this data. Comments are open until January 11, 2027, so jump in now to help shape smarter, smoother data rules that could speed up approvals and improve health outcomes. ## Abstract The Food and Drug Administration (FDA or Agency), is announcing a request for information (RFI) from interested parties to share perspectives on patient-level data access related to the use of real-world evidence (RWE) in regulatory decision-making for drugs and biological product submissions. The purpose of this RFI is to solicit input from interested parties on innovative solutions to address the challenges in submitting patient-level data for real-world data (RWD) analyzed in clinical studies included in a marketing application. Interested parties may include regulated industry, health information technology (HIT) vendors, academic medical centers, electronic data capture vendors, patient advocates, and other interested parties. ## Effects PRIA read - Sponsors must ensure patient-level RWD submission: cost, medium. If you are a drug or biologics sponsor, you must be able to submit patient-level real-world data (RWD) for any real-world evidence (RWE) used in clinical studies when required under 21 CFR 314.50 and 21 CFR 601.2. If you do not own the RWD, you should establish agreements with the data owners so th… - FDA cannot accept data-use terms that conflict with law: cost, medium. FDA states it often cannot sign data-use agreements (DUAs) that include terms conflicting with its legal obligations. Examples given include DUA terms requiring data destruction that conflict with federal recordkeeping, ownership or access terms that conflict with preserving administrative records,… - No acceptance of external database links; DMF/pre-IND routes available: mixed, medium. FDA does not accept links to external databases for patient-level RWD submissions. The notice explains third-party data providers may instead provide data to FDA by opening a pre-IND or a Type V drug master file (DMF), with the sponsor providing a letter of authorization to allow FDA to reference t… - Large, complex RWD create technical submission challenges: cost, medium. FDA notes real-world datasets (for example, longitudinal records, imaging, or multi-omics) are often substantially larger than typical clinical trial datasets, and that submission via traditional channels can be difficult. This creates technical challenges for data transfer, storage, and processing… - Stakeholders can comment by January 11, 2027: benefit, low. FDA is requesting public comments on patient-level data access for RWD/RWE and will accept electronic or written comments until January 11, 2027 (electronic filing accepted until 11:59 p.m. Eastern Time on that date). Interested parties named include regulated industry, health information technolog… ## Related documents - [2026-20848](https://policyrisk.com/federal-register/2026-20848): Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 2026-10-13 - [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11 - [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13 - [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29 - [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25 - [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27 ## Sources - [2026-22996 on federalregister.gov](https://www.federalregister.gov/documents/2026/11/12/2026-22996/patient-level-data-for-drugs-and-biological-products-submissions-containing-real-world-data-and) - [2026-22996 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-11-12/pdf/2026-22996.pdf) ## Related - [Previous: 2026-22995, Notice of Inventory Completion: Auburn University at Montgomery, Montgomery, AL](https://policyrisk.com/federal-register/2026-22995) - [Next: 2026-22998, Notice of Inventory Completion: William S. Webb Museum of Anthropology, Univers…](https://policyrisk.com/federal-register/2026-22998) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-22996 (as of 2026-11-12).