CTD Section 1.14.5 Report
Summary
Section Name:
Foreign labeling
Section Code:
1.14.5
Module Number:
1
Description:
This section should contain draft text of all labeling that is intended for a foreign market (non-USA) due to harmonization efforts between the FDA and other countries
Submission Timing
Marketing applications (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources