CTD Section 3.2.S.7.2 Report
Summary
Section Name:
Post Approval Stability Protocol and Stability Commitment
Section Code:
3.2.S.7.2
Module Number:
3
Description:
This section is used to determine expiry date on approved products. Do not provide a post-approval stability protocol and commitment until after the discussion of these items at late phase IND meetings
Submission Timing
Prior to or with marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources