Since September 15, 2021, technical rejection criteria have been added to the existing electronic common technical document (eCTD) validation criteria to enforce the deadlines regarding Study data standards.
All the studies belonging to sections of Module 4 and Module 5 where datasets are mandatory, according to the standards specified in the FDA Data Standards Catalog, will now require at least a simplified ts.xpt file even if the study started before the date when the submission of a full dataset became mandatory.
This rejection criteria will be applied differently depending on the Application Type and the Center that evaluates it (CDER or CBER).
Find the last Technical Rejection Criteria for Study Data here: https://www.fda.gov/media/100743/download
At Asphalion we are experts and can assist you in all your FDA eCTD submissions.
In case you need further information, you can contact us at: firstname.lastname@example.org