CTD Section 4.2.3.3 Report
Summary
Section Name:
Genotoxicity
Section Code:
4.2.3.3
Module Number:
4
Description:
(section heading, no text needed) this section should include all studies where the primary purpose was to detect or characterize genetic damage caused by a drug, divided into in vitro and in vivo categories
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