CTD Section 1.14.4.1 Report
Summary
Section Name:
Investigational brochure
Section Code:
1.14.4.1
Module Number:
1
Description:
A brochure that is provided to clinical investigators with a description of the drug and a summary of prior study results and description of possible risks and side effects (not required for sponsor-investigator INDs)
Submission Timing
Initial IND or IND amendments (if applicable)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources