CTD Section 3.2.S.4.5 Report
Summary
Section Name:
Justification of Specification
Section Code:
3.2.S.4.5
Module Number:
3
Description:
Provide a detailed explanantion of how the specifications and acceptance criteria were chosen
Submission Timing
Initial IND or IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources