CTD Section 4.2.3.7.3 Report
Summary
Section Name:
Mechanistic studies
Section Code:
4.2.3.7.3
Module Number:
4
Description:
Mechanistic studies to understand how the drug product or drug substance/s cause toxicity
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