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:

1. ‘REMS Supplement’ added in Submission Types and Description of Use Table
2. ‘REMS Supplement’ added as valid submission type for PAS and CBE-30 in Supplement-Effective-Date-Types and Descriptions of Use Table
3. ‘REMS Supplement’ added as valid submission type for submission sub-types of ‘application’,

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)