Two Policy Papers Outline CDER’s Role in Assessing REMS Plans

Two newly revised FDA policy papers outline how CDER will evaluate Risk Evaluation and Mediation Strategies (REMS) and REMS Assessment Reports.

The first paper governs REMS Assessment Methodology documents, which contain proposed methodological approaches and study protocols used to assess the efficacy of a REMS program. These can include surveys, drug use as documented by insurance claims or observational studies, and non-compliance and audit plans.

The second policy paper explains how CDER will review an applicant’s REMS Assessment Report. Every REMS must include a timetable for submitting multiple assessments of its efficacy.

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