CTD Section 4.2.3.3.1 Report
Summary
Section Name:
In vitro
Section Code:
4.2.3.3.1
Module Number:
4
Description:
Studies conducted in vitro (non-mammalian or mammalian cell system) that assess genetic damage caused by drugs
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