CTD Section 1.14.4.2 Report
Summary
Section Name:
Investigational drug labeling
Section Code:
1.14.4.2
Module Number:
1
Description:
The sponsor should use this section to detail all labels and labeling that is provided to each investigator
Submission Timing
Required in initial IND application or in amendments if changes are made
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources