CTD Section 1.1.5 Report
Summary
Section Name:
Form FDA 2253: Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use
Section Code:
1.1.5
Module Number:
1
Description:
Form to start regulatory review of promotional content
Submission Timing
Include with marketing applications, CDER INDs only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources