US FDA will be accepting eCTD submission only with U.S. Regional DTD V3.3 from1st March 2022
US FDA will no longer accepts eCTD submission with M1 V1.3, Comprehensive Table of Contents Headings and Hierarchy V1.2.2, U.S. Regional DTD V2.01 & U.S. Regional Stylesheet V1.1. and support will end on 1st March 2022. US FDA will update the eCTD submission standards documents to reflect these changes.
Do you need assistance to update your publishing software and submission processes to compliant with US FDA requirements?
Contact us at info@regorbit.com or +43 68110531332