CTD Section 4.2.3.4.2 Report
Summary
Section Name:
Short-or medium-term studies
Section Code:
4.2.3.4.2
Module Number:
4
Description:
This section contains study reports, where the primary purpose was to ascertain whether the drug causes tumor development over the short- or medium-term (<2 years duration)
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