CTD Section 1.16.2.3 Report
Summary
Section Name:
REMS Assessment
Section Code:
1.16.2.3
Module Number:
1
Description:
The REMS assessment plan should include an overview of the REMS objectives, requirements and materials
Submission Timing
Include in marketing application, postmarketing amendment
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources