CTD Section 5.3.5.4 Report
Summary
Section Name:
Other Clinical Study Reports
Section Code:
5.3.5.4
Module Number:
5
Description:
This section may include reports of interim analyses, controlled safety studies not reported elsewhere, studies unrelated to the claimed indication, reports of ongoing studies
Submission Timing
As early as initial IND application, revise as necessary
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources