CTD Section 4.2.3.7.7 Report
Summary
Section Name:
Other
Section Code:
4.2.3.7.7
Module Number:
4
Description:
These studies utilize specialized models or systems to investigate toxicity of a drug (such as toxicity to a specific organ, or in the context of a special population)
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