CTD Section 1.11.3 Report
Summary
Section Name:
Clinical/Efficacy information amendment
Section Code:
1.11.3
Module Number:
1
Description:
Document that provides a place to submit amendments to Clinical/Efficacy (Module 5) information
Submission Timing
IND amendment only (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources