ACUTA, ARIM, ARIM Publisher, eCTD, FDA, Uncategorized, Validator

FDA Validation Criteria to change July 27

On June 21, FDA announced changes to their eCTD validation criteria, to be implemented on July 27.

The first is to remove a low-severity item, #5025, which would highlight the lack of PDF-fillable forms.

The rest are a set of new validation rules, numbered 1-7, that were previously part of their Submission Acceptance criteria — generally you wouldn’t have gotten as far as Submission Validation previously if these issues were there. These new rules let FDA keep a single set of error codes (which I’m hoping makes them one step closer to two-way communications using eCTD 4.0, but then again, I’m still holding my breath for the next “Song of Ice and Fire”, “Kingkiller Chronicles” and “Gentleman Bastards” books). These are really such big errors that they should be caught by just a casual glance at the submission.

Code Description Impact
1 Duplicate Sequence Number Resubmit with next available sequence number
2 us-regional.xml missing Resubmit with a regional XML file
3 Single File Submission Submit more than one file with files and subfolders – you almost always need a form and/or a cover letter
4 Submission containing no files Even worse than #3
5 Application Mismatch Resubmit with matching application numbers in the FDA form and the us-regional.xml
6 Submission is not in eCTD format Seriously? Everything should be eCTD now
7 Fillable Form Not Included The fillable PDF form 356h (NDA/BLA), 2252 (ad/promo), or 1571 (IND) should be included

ACUTA is currently working on the release of ARIM (ACUTA Regulatory Information Management) version 3.3 to incorporate this change into our submission validation capabilities. We will also update the ACUTA Desktop Validator, and create a hotfix for ARIM 3.2. The projected release dates will be sent to customers in the next couple days, and this being a very small change should be able to be completed very shortly.

We do not anticipate releasing a hotfix for ARIM 2.3.3. Customers still using 2.3.3 will be contacted by support with guidance as to how they will be able to remain in compliance, and truly these are validation criteria that ARIM’s submission publishing pretty much can’t fail at, with the exception of the application number mismatch (#5), as that depends on some manual entry.

Please contact us for more information on upcoming updates of ARIM, or how we can move you today to agency-compliant publishing software and services.

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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