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What happens to your eCTD submission once you have sent it to the FDA?

When your eCTD arrives at the correct document room either on CD-ROM or into the Electronic Submission Gateway (ESG), the FDA will conduct a technical validation check on the submission to ensure that it can be opened, processed, and archived. In March of this year, the FDA issued the validation criteria to be used for their validation processes. Specifications for eCTD Validation Criteria version 1.0 outlines the items that will be checked in the eCTD and grades errors found by severity. If an eCTD passes technical validation, the FDA will acknowledge the submission as received on the business day that it arrived to the document room. If errors are found at a severity that requires correction (fails technical validation), the FDA will notify the Sponsor of the technical deficiencies and the submission will not be considered received until a corrected eCTD has been submitted and passed validation.

For more information on the validation criteria and receipt of eCTD submission by FDA please see the following website: http://www.fda.gov/cder/regulatory/ersr/validation_specs.htm.

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