CTD Section 4.2.3.4 Report
Summary
Section Name:
Carcinogenicity
Section Code:
4.2.3.4
Module Number:
4
Description:
(section heading, no text needed) This section contains study reports, where the primary purpose was to ascertain whether the drug causes tumor development, divided into subsections by study duration or special properties
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