CTD Section 1.16.2.4 Report
Summary
Section Name:
REMS Assessment Methodology
Section Code:
1.16.2.4
Module Number:
1
Description:
This section explains how the REMS requirements are assessed, and may include assessment category, selected metrics, related data sources, analytical tools and the frequency of assessment
Submission Timing
Include in marketing application, postmarketing amendment
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
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