CTD Section 5.3.4.2 Report
Summary
Section Name:
Patient PD and PK/PD Study Reports
Section Code:
5.3.4.2
Module Number:
5
Description:
This section should include reports on biomarkers, short-term studies of the main clinical effect, or secondary PD studies in patients
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