CTD Section 1.15.1.1 Report
Summary
Section Name:
Request for advisory comments on launch materials
Section Code:
1.15.1.1
Module Number:
1
Description:
Document to request FDA OPDP office to review and comment on promotional materials intended for dissemination to the public during the launch phase, included with Form 2253
Submission Timing
Include in marketing application (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources