CTD Section 1.12.5 Report
Summary
Section Name:
Request for a waiver
Section Code:
1.12.5
Module Number:
1
Description:
Section for any waiver request that does not fit into a specific subcategory in Module 1 (e.g. waiver of eCTD requirements, labeling requirements)
Submission Timing
Initial IND or IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources