On November 12, 2026, the Food and Drug Administration published Federal Register notice 2026-22996 (Docket No. FDA-2026-N-10742) in the United States, a request for information on patient-level data in drug and biological product submissions that contain real-world data and real-world evidence. The notice, signed by Deputy Commissioner Grace R. Graham, was filed on November 10, 2026 (91 FR 72875).
US drug and biologic sponsors submitting NDAs or BLAs containing real-world evidence, real-world data providers and vendors (claims, EHR, and registry data) supplying the US market, electronic data capture (EDC) vendors for FDA-regulated clinical studies using RWD, and health information technology (HIT) vendors serving US drug and biologic submissions must submit comments to Docket No. FDA-2026-N-10742 by January 11, 2027 on patient-level RWD access challenges, data-use agreement barriers with FDA, and technical solutions for submitting patient-level data in regulatory applications containing RWE, or FDA develops future RWD and RWE submission policy, data standards, and collaborative frameworks without that stakeholder's input. Electronic comments close at 11:59 p.m. Eastern Time at the end of January 11, 2027. Written comments are timely only if received on or before that date. Late comments will not be considered.
What does notice 2026-22996 ask about patient-level RWD?
Notice 2026-22996 does not add a new submission duty. It asks how sponsors and data holders can meet the existing one when they do not own the data, when a data-use agreement conflicts with FDA's legal obligations, or when the file is too large to transfer. Real-world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
FDA states that sponsors must be able to submit patient-level data for any RWD analyzed in a clinical study in a marketing application, when required under 21 CFR 314.50 and 21 CFR 601.2. The notice points to the August 2023 guidance, Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products. CDER and CBER use those records to rerun analyses.
Sponsors often lack authority to send patient-level records and must contract for submission and for inspection of source data. HIPAA (45 CFR parts 160 and 164) and EU GDPR transfers add privacy limits. A third party may open a pre-IND or a Type V drug master file under 21 CFR 314.420, with a letter of authorization. FDA does not accept links to external databases. Large longitudinal, imaging, and multi-omics files strain transfer, and FDA cannot sign a data-use agreement that requires destruction or that limits the administrative record or FOIA.
| Question | What FDA asks commenters to address |
|---|---|
| 1 | Opportunities and challenges of submitting patient-level RWD for submissions that propose RWE |
| 2 | Solutions where FDA cannot sign a conflicting data-use agreement, for NDA, BLA, DMF, or pre-IND filings |
| 3 | Receipt, retention, technical interoperability, and independent review of RWD submissions |
| 4 | How FDA might work with external parties on patient-level data for RWE |
Each comment should name the question by category and number. The notice is issued under 21 U.S.C. 393(b). Posted comments are public. Confidential material is a paper filing in two copies, one marked confidential and one redacted, under 21 CFR 10.20.
Who is exposed to this request for information?
The exposed actors are sponsors of NDAs and BLAs that rely on RWE, vendors of claims, EHR, and registry data sold into the US market, EDC vendors whose systems hold RWD for FDA-regulated studies, and HIT vendors that support those submissions. Academic medical centers and patient advocates may also comment. The notice adds no filing duty. It asks these parties to describe the constraints FDA will use in later policy.
Obsidian tracks 14 regulatory texts, in force, amended, or in preparation, under FDA 21 CFR in the United States, as of November 2026. That count is a register of texts, not a statement that each text governs this RFI.
What should a comment cover before January 11, 2027?
A useful comment answers at least one question with a mechanism FDA can use in later RWD and RWE policy, collaborative frameworks, or IT changes.
- State whether the sponsor can obtain a right to submit patient-level RWD, and what the holder will not authorize.
- Propose contract language without a destruction clause or a limit on the administrative record or FOIA.
- Describe a transfer method for large files that does not use a link to an external database.
- Say whether a Type V DMF or a pre-IND under 21 CFR 314.420 works, and flag HIPAA or GDPR blocks on the NDA or BLA.
What happens if a stakeholder stays silent?
Silence is not a violation of notice 2026-22996. It sets no penalty, no application refusal, and no standard that takes effect on January 11, 2027. FDA will plan RWD and RWE policy and any collaborative framework from the comments it receives. A party that does not file leaves those choices to other commenters and to 21 CFR 314.50, 21 CFR 601.2, and the August 2023 guidance. Continuous, per-jurisdiction monitoring surfaces a Federal Register notice of this kind on its publication date.
The PDF is the Government Publishing Office copy of FR Doc. 2026-22996. Confirm that the submission uses patient-level RWD, identify who holds the data, and brief regulatory affairs, the data vendor, and counsel on the January 11, 2027 close.
