CTD Section 1.14.1.4 Report
Summary
Section Name:
Label comprehension studies
Section Code:
1.14.1.4
Module Number:
1
Description:
This section is primarily required for nonprescription drugs; FDA may require for prescription drugs on a case-by-case basis
Submission Timing
Only if required by FDA
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources