CTD Section 1.13.5 Report
Summary
Section Name:
Summary of manufacturing changes
Section Code:
1.13.5
Module Number:
1
Description:
In the Sponsor's annual report, if there are updates to manufacturing, those changes should be reported in this section
Submission Timing
IND amendments (annual reports only and if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources