Resubmission of SEND with a Study Report
FDA’s June 2026 guide distinguishes changed from unchanged SEND datasets when a final or amended study report follows a draft: changed datasets are replaced, while unchanged datasets need not be resubmitted; an updated nSDRG is recommended.
When SEND datasets change between a draft and final study report, submit replacement datasets as current FDA guidance describes. If they do not change, the guide says dataset resubmission is unnecessary and recommends an updated nSDRG.
Key details
Important caveats
Scope Boundary
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, Data Standards Catalog, and eCTD specifications before relying on version-sensitive requirements.
Further guidance
Content
This is current FDA technical-conformance guidance for electronic study-data submissions; recheck the current FDA guide, supported standards, Data Standards Catalog, and eCTD specifications before relying on version-sensitive requirements.
Purpose
When SEND datasets change between a draft and final study report, submit replacement datasets as current FDA guidance describes. If they do not change, the guide says dataset resubmission is unnecessary and recommends an updated nSDRG.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- Study Data Technical Conformance Guide - Technical Specifications Document (opens in a new tab)U.S. Food and Drug Administration · Current FDA technical specifications for standardized clinical and nonclinical study-data submissions, including reviewer guides, datasets and eCTD organization.