CTD Section 1.16.1 Report
Summary
Section Name:
Risk Management (non-REMS)
Section Code:
1.16.1
Module Number:
1
Description:
For investigational drugs that don't require a REMS, a Risk Management Plan is needed and should include risk assessment, risk minimization and ongoing monitoring of known and potential risks
Submission Timing
Not required, but FDA highly encourages sponsors to proactively manage known or anticipated risks
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources