CTD Section 3.2.P.5.6 Report
Summary
Section Name:
Justification of Specification(s)
Section Code:
3.2.P.5.6
Module Number:
3
Description:
Provide justification for any proposed drug product specifications.
Submission Timing
Initial IND, update as needed
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources