Due to a lack of standardization of safety data analysis and visualization, inconsistencies in adverse event definition, categorization, analysis, and presentation have been noted in marketing applications.
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research’s Office of New Drugs led the development of two documents to facilitate review of safety data and improve safety signal detection. The first document, the FDA Medical Queries, are a standardized approach to group preferred terms. The second document, the Standard Safety Tables and Figures Integrated Guide, are standardized methods for visualization of clinical trial safety data into tables and figures. The agency values transparency and collaboration with external stakeholders-therefore both documents have been made available for public comment through an FDA-created docket.
On September 14, 2022 the Duke-Margolis Center for Health Policy and the FDA held the following public workshop presenting FDA's work and perspective on premarket review of safety data. The FDA documents will served as a launch point for broader conversations on best practices and innovative approaches for advancing premarket safety signal analytics.