Submit a Sample eCTD to the FDA

Sample eCTD Submission Process

FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and offer the following steps to help smooth the process. Please follow the directions below in order to submit your sample.

1. Review the eCTD Specifications prior to proceeding
2. Request a Sample Application Number
   
   Initiating contact with the FDA helps to begin a productive dialog, ensuring that both technical sides are working from the same set of information. When ready to begin creating an eCTD, email us at ESUB@fda.hhs.gov to inform us of your plans. When sending an email please include the following:
   • Contact Person Name - This will be the main contact during the sample submission phase.
   • Contact Person's Company Name
   • Contact Person's Mailing Address
   • Contact Person's Phone Number
   • Contact Person's Email Address
   • Date When You Plan To Submit An Actual Application
   • Description of Sample to be evaluated including application type if known (i.e. eCTD IND, ANDA, NDA, DMF; eCTD Cross Application Linking; or SDTM dataset)
   Note:  The information you provide in your email request for a sample number should also be provided in the cover letter of your sample.
3. The FDA provides a sample application number for the sample submission
   
   Once you have submitted your contact information, a technical representative from the FDA will contact you and assign a number for the sample.
4. Submit a sample submission using the specifications for testing
   
   This is a sample submission and is not considered an official submission.  If you are testing an eCTD sample, please review the recommended contents of the sample submission.
5. The FDA tests sample submission
   
   The FDA will process the sample submission to ensure that it conforms to FDA Guidance, Specifications as well as ICH specifications and guidelines. These tests include, but are not limited to DTD validation, verification of file checksums, verification of the presence of the modified file, and identification of missing files.
   
   This sample eCTD submission will NOT be reviewed by an FDA reviewer during this initial test. The FDA will provide the participant with a report highlighting the errors found during the initial processing of the sample eCTD submission.
6. Resolve any technical issues with the submission
   
   You should correct all errors identified by the FDA and seek clarification if necessary.
7. Resubmit sample submission
   
   You should resubmit the corrected sample submission in a revised sample eCTD submission with the same sequence number.
   
   After the successful completion of these steps, the submissions should be technically ready to be officially submitted to the Agency. This testing phase does not involve any review of the content of the submission and is intended to only resolve technical issues. For additional information, contact the FDA at ESUB@fda.hhs.gov.