CTD Section 1.13.15 Report
Summary
Section Name:
Development safety update report (DSUR)
Section Code:
1.13.15
Module Number:
1
Description:
A report in which Sponsors present a comprehensive discussion of all safety issues that have ever arisen in clinical investigations, and should demonstrate adequate monitoring and evaluating the evolving safety profile of the investigational drug (note: this report should not be used to disclose any new safety issues)
Submission Timing
IND amendments (annual reports only)
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources