CTD Section 2.7.4 Report
Summary
Section Name:
Summary of Clinical Safety
Section Code:
2.7.4
Module Number:
2
Description:
This section should serve as a summary of all data relevant to safety in the intended patient population and should include discussion of the extent of exposure to the drug, common adverse events, and serious adverse events
Submission Timing
As early as initial IND application (see note), completed by marketing application
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources