Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard
The REMS Public Dashboard is an interactive web-based tool that will allow for the analysis of REMS data in a user-friendly way. The intention of this tool is to expand efficient access to data and report-generating capabilities of REMS programs for health care providers, research organizations, academia, industry, and others.
Launch the FDA Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard
FDA has developed this secure REMS Public Dashboard to improve data access and transparency. Data used in this dashboard are pulled from existing data files available on the REMS@FDA website. Users can create 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active REMS programs, elements to assure safe use, REMS modifications, revisions, and released REMS programs that are no longer in effect. FDA is continuing to explore other data sources to continue to augment the information in the REMS Public Dashboard. The agency anticipates this enhanced transparency will help to stimulate increased awareness and understanding of the REMS programs.
Questions about the REMS Public Dashboard:
- What information is available in the REMS Dashboard?
The REMS Dashboard includes information about approved REMS Programs such as Total REMS, Active REMS, Elements to Assure Safe Use (ETASU), Shared System REMS, Modifications, Revisions, and Released REMS.
- What is the data source for the dashboard?
The data on REMS Dashboard are from the data source that supports REMS@FDA.
- How often is the REMS Dashboard updated?
FDA updates the dashboard weekly.
- What are the benefits of the REMS Dashboard?
FDA has approved more than 300 REMS programs and over 700 REMS modifications since 2008. The REMS dashboard was developed for efficient report generating capabilities, data retrieval, and analysis of REMS information. Availability of the dashboard for the public and other stakeholders including FDA staff allows for efficient access and visualization of the REMS data to improve transparency for the FDA drug safety programs.
- Are there some limitations of the REMS dashboard?
The dashboard is limited to descriptive methods that is not intended for trend analysis or cross-comparisons. The data on the dashboard is limited to the accuracy of the data source that supports REMS@FDA.