CTD Section 5.3.5.1 Report
Summary
Section Name:
Study Reports and Related Information of Controlled Clinical Studies Pertinent to the Claimed Indication
Section Code:
5.3.5.1
Module Number:
5
Description:
Human studies using a control arm should be placed in this section
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