CTD Section 5.3.2.3 Report
Summary
Section Name:
Reports of Studies Using Other Human Biomaterials
Section Code:
5.3.2.3
Module Number:
5
Description:
Use this section for studies using a biomaterial other than plasma or hepatic tissues/cells
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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