CTD Section 1.15.1.8 Report
Summary
Section Name:
Correspondence accompanying materials previously missing or rejected
Section Code:
1.15.1.8
Module Number:
1
Description:
The Sponsor can use this section to address deficiencies in previously missing or rejected promotional materials without having to resubmit the entire application (amendment to marketing application)
Submission Timing
Include in marketing application (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources