CTD Section 4.2.3.7.2 Report
Summary
Section Name:
Immunotoxicity
Section Code:
4.2.3.7.2
Module Number:
4
Description:
These studies assess the potential for a drug to cause adverse effects on the immune system, such as immune suppression or hypersensitivity reactions
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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