CTD Section 1.13.12 Report
Summary
Section Name:
Status of postmarketing study commitments and requirements
Section Code:
1.13.12
Module Number:
1
Description:
In the Sponsor's annual report, if there are updates to nonclinical studies, those changes should be reported in this section
Submission Timing
Marketing application amendments (annual reports only and if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources