Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns beyond routine drug labeling to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of a medication. While all medications have labeling that informs health care stakeholders about medication risks, limited number medications require a REMS.

FDA maintains a publicly available website listing drug products with approved REMS that are currently active and their associated materials, under REMS@FDA. The Office of Communication (OCOMM) helps organize and post REMS data under REMS@FDA.

REMS Dashboard is an analytical dashboard for REMS data in Qlik Sense application. Qlik Sense is a business intelligence (BI) and visual analytics platform that supports a range of use cases, including centrally deployed guided analytics apps and dashboards, custom and embedded analytics, and self-service visualization, all within a scalable, governed framework.

The REMS Public Dashboard includes information about approved REMS Programs such as Total REMS, Active REMS, Elements to Assure Safe Use (ETASU), Shared REMS, Modifications, Revisions, and Released REMS. FDA will continue to explore other data sources to further expand the data analysis capabilities of this dashboard in the future.

The REMS data files available on REMS@FDA are the data sources of REMS Dashboard. Once these REMS data sets have been collected and cleaned they are imported into the Qlik Sense. The predefined charts and tables can then be visualized for various analysis based on REMS business needs.

FDA has approved nearly 300 REMS programs and over 700 REMS modifications since 2008. The REMS dashboard was developed to assist FDA staff with efficient report generating capabilities, data retrieval, and analysis of REMS information available in the REMS@FDA Website. Availability of this tool for the public and other stakeholders allows for more efficient access and visualization of the REMS data to improve transparency for FDA drug safety programs.

The data in the REMS dashboard comes from the data files on REMS@FDA website. The results of data retrieved from REMS dashboard is dependent on the accuracy of these data files. The dashboard is intended for descriptive analyses and not for cross-comparison of REMS.

FDA will update the dashboard using the REMS@FDA datafiles on a monthly basis. Data on the REMS dashboard is current through the posted date at the bottom left of the dashboard page.

Chrome, Microsoft Edge and Internet Explorer are recommended to access the REMS Public dashboard. The recommended screen resolution for desktop or laptop is 1920x1080.

Yes, the user manual is available which includes the overview, and sample test cases of REMS dashboard.

User Manual

When the user hover over any chart or table, a symbol is displayed on the right top corner of the chart or table. Clicking on this icon will enable user to view the chart or table in full screen mode. To exit the full screen mode, click the X on the top right corner of the chart or table.

Yes, the dashboard provides extensive filtering capabilities on both charts and tables. To filter data in a table, for example, filtering by ETASU:

1.    Click on one or multiple columns or rows. You may also click and drag multiple rows or columns to select them for filtering data.

2.    Click on the icon to confirm your selection.

To filter data in a Bar Chart, for example, filtering by Year:

1.    Click on one or multiple bar. You may also click and multiple bars or to select them for filtering data.

2.    Click on the icon to confirm your selection.

If a user wishes to clear the filter, find the filter name from the Gray bar located on top of Blue selection bar and click [x].

Another way : when making the selection , user can also select red cross mark to clear the filter.

Yes, some of the results from the dashboard can be exported or downloaded: Right-click on any table or chart in the dashboard and click on the “Export” option if available. You may choose from the following three options for exporting and downloading data:

1.    Export as an image: exports a snapshot of the table or chart that you are viewing to an image file.

2.    Export to PDF: exports a snapshot of the table or chart that you are viewing to a PDF file.

3.    Export data: exports the underlying data of the table or chart that you are viewing to a Microsoft Excel (.xlsx) file.

For more details, please refer to User Manual-Section C: How to download data from the Bar graph and table.