CTD Section 4.2.3.4.3 Report
Summary
Section Name:
Other Studies
Section Code:
4.2.3.4.3
Module Number:
4
Description:
This section contains study reports, where the primary purpose was to conduct more specialized carcinogenicity studies
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