CTD Section 1.4.3 Report
Summary
Section Name:
List of authorized persons to incorporate by reference
Section Code:
1.4.3
Module Number:
1
Description:
Document provided by the holder of the Drug Master File (DMF) that contains a complete list of parties that are allowed to reference that DMF
Submission Timing
Include in initial IND or amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources