CTD Section 4.2.3.7.4 Report
Summary
Section Name:
Dependence
Section Code:
4.2.3.7.4
Module Number:
4
Description:
These studies assess the drug's potential to cause physical dependence. Note: many drugs can cause dependence without the rewarding properties that are the hallmark of drugs that have abuse potential
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