FDA Talks Automated Technical Rejection

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At the DIA Doc Management conference, the FDA presenters spoke with one voice on their intention to start rejection sequences that have what they consider significant technical flaws.

Gary Gensinger reviewed the guidance that has been issued by FDA on this topic (see my previous post) and the three types of eCTD Validation:

  • Automated Submission Receipt (ASR) Validation – automated step performed as your submission is accepted and loaded into CDER’s tracking system
  • eCTD Tool – detailed automated technical validation performed after the submission has been registered with the tracking system. The FDA uses GlobalSubmit VALIDATE 5 for this validation.
  • Qualitative Validation – checks performed by staff members for problems such as TOC issues, bookmark and hyperlink issues, or dataset problems

The most common problems encountered during ASR validation include:

  1. – No Electronically Fillable Form Found (Gary noted that the lack of a fillable form essentially turns your gateway submission into a media submission and slows its availability to the reviewers)
  2. No 356h, 1571, or 2252 Form Found
  3. Unable to determine location of form
  4. Application number in us-regional.xml and form do not match
  5. Mismatch between application type and form

The eCTD tool validation done with GlobalSubmit VALIDATE 5 enforces the criteria defined in Specifications for eCTD Validation Criteria. For those of you who have received validation reports back from FDA, those reports were generated directly from GS VALIDATE.

Virginia Ventura also discussed validation in her presentation “CDER eCTD & Validation, Issues Update”. As always, Ginny’s presentation gave helpful, practical advice. The following were cited as the reasons for rejection:

  • Duplicate Submission
  • us-regional.xml / form mismatch
  • us-regional.xml cannot be read / nonstandard eCTD
  • Sent to the wrong Center
  • Portions sent outside the eCTD (extra folders with non-referenced files)
  •  Empty folder

The following points were made about Rejections

  • Rejections will be communicated by fax to the fax number indicated in your cover letter
  • If the submission is a gateway submission, rejection will also result in a return gateway message – check your inbox!
  • If your Module 1 is incorrect, do not be surprised when your submission is rejected! CDER will not correct your Module 1.

Author: GS

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