CTD Section 5.3.3.4 Report
Summary
Section Name:
Extrinsic Factor PK Study Reports
Section Code:
5.3.3.4
Module Number:
5
Description:
Studies to assess the effects of extrinsic (drug-drug interactions, diet, smoking, alcohol use) factors should be placed here
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