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: ‘REMS Supplement’ added in Submission Types and Description…

FDA has updated the guideline for eCTD Technical Conformance Guide (v1.3). In this version FDA; Updated/Clarified following sections; Section Number Updation and Clarification Section 2.5 (eCTD Submission Tracking and Life Cycle) Heading name updated from eCTD Life Cycle to eCTD…