Advancing Premarket Safety Analytics

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Public Workshop

Advancing Premarket Safety Analytics

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The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research’s Office of New Drugs has just published the two documents to facilitate internal review of safety data. The agency values transparency and collaboration with external stakeholders—therefore both documents have been made available for public comment through an FDA-created docket.
Event Graphics Including Name Time and Date of Event

 

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 will hold a public workshop presenting FDA's work and perspective on premarket review of safety data. The newly released FDA documents will serve as a launch point for broader conversations on best practices and innovative approaches for advancing premarket safety signal analytics.
 

Background:

The FDA in collaboration with the Duke-Margolis Center for Health Policy will host a one-day virtual meeting focused on advancing premarket safety analytics. 


Significant Inconsistencies are noted in how adverse events are categorized, analyzed, and presented in marketing applications. To help overcome these challenges, the FDA’s Center for Drug Evaluation and Research’s Office of New Drugs developed two documents to facilitate internal 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 have made both documents available for public comment through an FDA-created docket.

 

Meeting Objective:

FDA will present their enhanced work and perspective on premarket review of safety data. The FDA documents will serve as a launch point for broader conversations on best practices and innovative approaches for advancing premarket safety signal analytics.

Duke-Margolis Planning Team

Brian Canter Headshot

Brian Canter, Ph.D.

Policy Research Associate

Dure Kim Headshot

Dure Kim, PharmD

Assistant Research Director