CTD Section 1.16.2.1 Report
Summary
Section Name:
Final REMS
Section Code:
1.16.2.1
Module Number:
1
Description:
The final version of the REMS that has been approved by FDA goes in this section
Submission Timing
Include in marketing application, postmarketing amendment
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources