U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
FDA eCTD Overview and Submission WBT
Validating eCTD Submissions
Why Are Submissions Rejected?

You invest a great deal of time in your eCTD submissions. The last thing you want to happen is for your submission to be rejected. What are the top reasons that eCTD submissions get rejected?

Error Possible Cause
Duplicate sequence submission received The sequence number was previously submitted.
us-regional.xml/form mismatch The application number in the us-regional.xml and the application number on the FDA form did not match.
Submission sent to the wrong Center The submission was meant for CBER but inadvertently sent to CDER.
No data received There were no files/data in the folder submitted.
Corrupted or broken media received The files submitted were corrupted and/or physical media were broken and could not be read.
Submission is not in standard eCTD format There was no us-regional.xml file or index.xml file provided with the submission.

FDA uses a commercial off-the-shelf product to validate eCTD submissions. For more information, review Specifications for eCTD Validation Criteria.

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