CTD Section 4.2.3.5.3 Report
Summary
Section Name:
Prenatal and postnatal development, including maternal function
Section Code:
4.2.3.5.3
Module Number:
4
Description:
These studies test for adverse effects following exposure of the maternal animal from implantation through weaning to evaluate effets on the pregnant or lactating female and development of the offspring up to sexual maturity
Submission Timing
As early as initial IND application, revise as necessary
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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