CTD Section 4.2.3.5.1 Report
Summary
Section Name:
Fertility and early embryonic development
Section Code:
4.2.3.5.1
Module Number:
4
Description:
These studies test for adverse effects resulting from treatment initiation prior to mating of males and/or females and continued through mating and implantation
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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