U.S. Food and Drug Administration
Protecting and Promoting Your Health
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Center for Drug Evaluation and Research
FDA eCTD Overview and Submission WBT
Validating eCTD Submissions
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Validation Checks

Validate all eCTD submissions prior to sending to the FDA.

FDA may perform additional validation checks for both eCTD and non-eCTD submissions to ensure that submissions are processed and routed accurately and in a timely fashion.

Additional validation checks include:

What additional guidance is available on validation?

A checklist titled, FDA Checklist, with two items on the checklist: Does the application form submitted match the application type? Is the application number consistent?
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