CTD Section 1.16.2.2 Report
Summary
Section Name:
Draft REMS
Section Code:
1.16.2.2
Module Number:
1
Description:
If FDA determines that the drug product requires a REMS, the sponsor can propose a REMS 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