CTD Section 1.16.2.6 Report
Summary
Section Name:
REMS Modification History
Section Code:
1.16.2.6
Module Number:
1
Description:
Document that tracks the changes that have been made to the REMS plan
Submission Timing
Include in marketing application, postmarketing amendment
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources