CTD Section 4.2.3.5.4 Report
Summary
Section Name:
Studies in which the offspring are dosed and/or further evaluated
Section Code:
4.2.3.5.4
Module Number:
4
Description:
These studies are those which involve transgenerational dosing and evaluation, where the offspring are dosed directly (not just indirect exposure through the parents)
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