CTD Section 1.3.2 Report
Summary
Section Name:
Field Copy Certification
Section Code:
1.3.2
Module Number:
1
Description:
A letter to the district office notifying that eCTD submission will be submitted to FDA, and should contain: drug and application number, FDA center and division, and a statement that the application is in eCTD format
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources