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 Phlexglobal 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
- Promotional Materials for one product submitted to a different product
- 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
- Form 2253 Box 3
- Single Annotated Label submitted under Section 1.14
- Labeling submitted under Section 1.14
- Product Labelling not submitted under 1.14.6
- Incorrect Application Number
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