Common Errors Seen in Promotional Submissions in eCTD and How to Avoid Them

By 20. November 2019Blog

Recently, the FDA held a free webinar in its CDER Small Business and Industry Assistance (SBIA) Webinar Series on “OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them”. The Cunesoft team took part in this webinar and created a summary of most common errors seen in promotional submissions in eCTD format.

Common Errors – Summary:

  • Common Errors
    • Incorrect Application Number
      • Promotional Materials for one product submitted to a different product
        • Submitter will need to revise and resubmit
      • Same 2253 for multiple Application Types
        • Some companies modify to make it for BLA, NDA, etc. You need to have one per application type – BLA, NDA, IND, ANDA
      • Incorrect Application Number in Cover Letter or Form 2253
    • Incorrect Material Document Type Code
      • Not matching US regional file
    • Audience Type in US-regional file doesn’t match the Cover Letter or Form
      • FDA sees this about once a day now – the US regional file and the form do not match
    • Issue Date in US-regional file improperly formatted
      • Correct format is YYYYMMDD
    • Orphan files included in Submission
      • Make sure the files are in the tree correctly – if not the file hangs out of order and gives them an error
    • Submission ID issues
      • The Submission ID field allows a submission to be linked to a previous eCTD Submission
      • Submitting an incorrect Submission ID can result in delayed processing
      • When submitting files that should be linked, the Submission ID field should match the previous Submission’s Sequence Number
        • Ex: The Submission ID of an Advisory Resubmission should match the Sequence Number of the Original Advisory
      • Form 2253 Errors
        • Product Labelling not submitted under 1.14.6
          • Excluded or submitted under a different heading
          • This will be rejected
        • Materials not submitted under Section 1.15.2.1
          • Social Media accounts
        • Including a Cover Letter under a Correspondence Heading
        • Including a Form 356(h)
          • Do not submit for any reason – this will cause a rejection
        • Advisory/Accelerated Approval Errors
          • Labeling submitted under Section 1.14
            • Single Annotated Label submitted under Section 1.14
              • Should be under 1.15.2.1.3 for each material
            • Clean copy submitted under Section 1.14.2 or 1.14.6
              • Not required
            • Hyperlinks to external sites or resources
              • Never link to any websites – labelling usually tries to include these links
            • Submitting a Withdrawal instead of a General Correspondence
              • General Correspondence should be used to notify Agency that Submitter will no longer wait for Advisory Comments and plans to disseminate materials
              • Withdrawal Heading should only be used when Materials will not be disseminated publicly
            • Grouped Submission Errors
              • Form 2253 Box 3
                • “Multiple Products” box should be checked if submitting as a group
              • Application List in US-regional file doesn’t match Application List with Form 2253 or Cover letter
              • PIs for all Products in Group not included
                • All copies of PI’s for all products included in the group
              • Supplemental Application List
                • Should be placed under the same heading as Form 2253

 

If you wish to watch a webinar recording or get access to slides – please follow the link: https://www.fda.gov/drugs/news-events-human-drugs/webinar-opdp-electronic-submissions-common-errors-ectd-and-how-avoid-them-oct-25-2019-10252019