CTD Section 4.2.1.1 Report
Summary
Section Name:
Primary Pharmacodynamics
Section Code:
4.2.1.1
Module Number:
4
Description:
This section should include all studies where the primary purpose was to find the mode of action or effect related to desired therapeutic target
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