CTD Section 4.2.3.5 Report
Summary
Section Name:
Reproductive and Developmental Toxicity
Section Code:
4.2.3.5
Module Number:
4
Description:
(section heading, no text needed) Studies conducted to assess whether a drug impacts ability to produce offspring, maintain a pregnancy, or offspring viability. Divided into subsections based on timing of parental exposure and indirect exposure of offspring, and/or if offspring were dosed directly
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