For NDAs, BLAs, and ANDAs submitted to FDA, any studies started after 17 December 2016 must be accompanied by study data in standardized formats (for commercial INDs, the cutoff date for new studies is 17 December 2018). This includes both clinical and nonclinical studies. To enforce this new requirement, FDA has added new technical rejection criteria for study data to the existing eCTD validation criteria.
What does this mean? FDA may refuse to file (RTF) for NDAs and BLAs, or refuse to receive (RTR) for ANDAs that don’t pass the new validation criteria.
One of the most important changes is the requirement of a Trial Summary (TS) dataset (ts.xpt). This dataset is now required for many m4 and m5 sections, even if the study started prior to 17 December 2016. Thankfully, this dataset is essentially a single line of text that just provides the start date of the study. Even if you don’t already have this dataset, it should not be difficult for your statistician to generate it quickly.
Including the check for the TS dataset, FDA added four new validation criteria: numbers 1734, 1735, 1736, and 1737. For complete details on these new technical rejection criteria for study data, see FDA’s “Technical Rejection Criteria for Study Data” document, issued on 22 June 2017.