Author: masuuglobal
US FDA Updated eCTD Technical Conformance Guide (v1.3)
FDA has updated the guideline for eCTD Technical Conformance Guide (v1.3). In this version FDA; Updated/Clarified following sections;
US FDA Updated eCTD Module 1 Specifications Version 2.4
FDA has updated the guideline for module 1 specifications version from v2.3 to v2.4. Summary of Changes for Version 2.4 Added eCTD Submission Type ‘REMS Supplement’. The updated sections are listed below: