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About this Virtual Meeting:

FDA and the Duke-Margolis Center for Health Policy will host a one-day virtual meeting focused on advancing pre-market safety analytics.

Due to lack of standardization of safety data analysis and visualization, inconsistencies exist in how adverse events are defined, categorized, analyzed, and presented in marketing applications. FDA led the development of two documents to facilitate review of safety data:

1. A standardized approach in grouping preferred terms known as the FDA Medical Queries (FMQ).
2. Standardized methods for visualization of safety data into tables and figures known as the Standard Safety Tables and Figures Integrated Guide (STF-IG).

The agency values feedback from external stakeholders and has made both documents available for public comment through an FDA-created docket.

Meeting Objective:

FDA will present its work and perspective on pre-market review of safety data. The FMQ and STF-IG will serve as a launch point for broader conversations on best practices and innovative approaches for advancing pre-market safety signal analytics.

Meeting Information and Registration:

This virtual workshop is open to the public with no cost to attend, but registration is required. Register here.

View the draft agenda here.

Contact:

For questions regarding this event, please contact:

Christopher Smith, PharmD, MPH, MSCS, BCPS, RAC
Office of Drug Evaluation Science
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
ONDbiomedicalinformatics@fda.hhs.gov