FDA Launches New Public Dashboard for REMS Data - Drug Information Update

U.S. Food and Drug Administration sent this bulletin at 01/20/2022 11:54 AM EST

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Launches New Public Dashboard for REMS Data

The U.S. Food and Drug Administration launched a new public dashboard for medications with an approved Risk Evaluation and Mitigation Strategy (REMS). The REMS Public Dashboard is a user-friendly functional tool that improves access to data for certain drugs with serious risks that need additional requirements to ensure safe use.

FDA has approved nearly 300 REMS programs and more than 700 REMS modifications since 2008. This new dashboard includes visualizations and charts for total and active REMS programs, elements to assure safe use, REMS modifications, revisions, and released REMS programs that are no longer in effect. Data used in this dashboard are pulled from existing REMS data files available on REMS@FDA. FDA will continue to explore other data sources to further expand the data analysis capabilities of this dashboard in the future.

For more information on using the REMS Public Dashboard, please visit the REMS Public Dashboard page and the REMS dashboard FAQ page.

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