CTD Section 1.15.1.4 Report
Summary
Section Name:
Presubmission of non-launch promotional materials for accelerated approval products
Section Code:
1.15.1.4
Module Number:
1
Description:
Annotated and clean copies of promotional materials for accelerated approval products to be reviewed by advisory committee
Submission Timing
Include with marketing applications that are seeking accelerated approval designation (after launch phase)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources