As one of the last actions in 2016 (effective December 17, 2016) the FDA enforced some new criteria that will allow them to reject an eCTD submission if there is non-compliance with key study data requirements.
FDA notes in their guidance “The standards apply to the following types of submissions to CDER and CBER:
- NDAs, ANDAs, BLAs, and all subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect.
- Commercial INDs (for products that are intended to be distributed commercially).”
There are different severities for these problems.
- Demographic dataset (DM) and the define.xml must be submitted in Module 4 for nonclinical data; DM dataset,
the subject-level analysis dataset (ADSL) and define.xml must be submitted in Module 5 for clinical data
- Trial Summary (TS) dataset must be present for each study in eCTD section 4.2 and 5.3
- Correct STF file-tags must be used for all standardized datasets in section 4.2 and 5.3
- For each study in eCTD section 4.2 and section 5.3, no more than one dataset of the same name should be
submitted as new
Some key information about this:
- Clinical and nonclinical trials that will be reviewed by CDER/CBER must use the standards in the FDA Data Standards Catalog
- FDA will validate submissions upon receipt and will assess conformance to required study data standards
- A technical rejection notice will be sent if the submission fails validation
- Customers must adhere to the Study Data Technical Conformance Guide when preparing submission for FDA review
- FDA will provide 30 days’ notice on the FDA eCTD Website prior to the validation criteria being effective