CTD Section 4.2.1.4 Report
Summary
Section Name:
Pharmacodynamic Drug Interactions
Section Code:
4.2.1.4
Module Number:
4
Description:
This section should include all studies where the primary purpose was to find or characterize potential drug-drug interactions (when two or more drugs are administered in the study, or the patient population is on some preexisitng therapy prior to recieving the study drug)
Submission Timing
As early as initial IND application, revise as necessary
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources