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active REMS programs, elements to assure safe use, REMS modifications, revisions, and released REMS programs that are no longer in effect.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:
How often will the REMS Public Dashboard be updated?
FDA will update the dashboard using the REMS@FDA data files on a regular basis. Data on the REMS dashboard are current through the posted date at the bottom left of the dashboard page.
What are the benefits of the REMS Public Dashboard?
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 stakeholders allows more efficient access and visualization of the REMS data to improve transparency for FDA drug safety programs.
What are some of the limitations of the REMS Public Dashboard?
The data in the REMS dashboard come from the data files on REMS@FDA website. The results of data retrieved from REMS dashboard are dependent on the accuracy of these data files. The dashboard is intended for descriptive analyses and not for cross-comparison of REMS.
What information is available in the REMS Public Dashboard?
The REMS dashboard includes information about approved REMS programs such as total REMS, active REMS, elements to assure safe use, 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.