The Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard: Improving Transparency of Regulatory Activities.

Abstract

This brief paper aims to describe the Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard launched by the US Food and Drug Administration (FDA) in December 2021. The FDA REMS Public Dashboard can be accessed through the REMS@FDA website. The dashboard was developed in Qlik Sense® to support a user-friendly interactive web-based tool that allows healthcare providers, patients, researchers, pharmaceutical companies, and regulators to readily access and visualize REMS information. The dashboard includes eight separate pages to capture information on all REMS, active REMS, REMS with elements to assure safe use, shared system REMS, REMS modifications, REMS revisions, released REMS, and REMS Summary; for REMS programs approved from 2008 to the present. Most of the pages allow users to choose different REMS characteristics to visualize and stratify the data by variables such as REMS approval time, application type, or REMS elements. This interactive platform is intended to allow users to quickly visualize trends over time and locate details of the REMS programs to inform emerging research and regulatory issues in the context of current drug safety. The FDA continues to explore ways to enhance public access of the REMS information in near real-time through the REMS Public Dashboard.