The U.S. Food and Drug Administration (FDA) is taking proactive steps to standardize and enhance the review of safety data for drug marketing applications. Recognizing inconsistencies in adverse event analysis and presentation, the FDA’s Center for Drug Evaluation and Research (CDER) has developed key resources to facilitate clearer and more effective safety signal detection. These efforts will be the focus of a public workshop hosted by the FDA and the Duke-Margolis Center for Health Policy on September 14, 2022.
To address the noted inconsistencies in how safety data is handled across marketing applications, the FDA has introduced two pivotal documents. The first, FDA Medical Queries (FMQ), provides a standardized approach to categorize preferred terms related to adverse events. The second, the Standard Safety Tables and Figures Integrated Guide (STF-IG), offers standardized methods for visualizing clinical trial safety data. These initiatives aim to bring greater clarity and efficiency to the premarket review process, ultimately improving patient safety.
This workshop is designed to present the FDA’s perspective and detailed work on premarket safety data review. It will use the newly released FDA documents as a starting point to foster a broader discussion on best practices and innovative approaches within the field. By engaging with external stakeholders, the FDA seeks to collaboratively advance premarket safety signal analytics, ensuring a more robust and consistent approach to drug safety evaluation. The agency has made both the FMQ and STF-IG documents available for public comment through an FDA-created docket, emphasizing its commitment to transparency and collaborative improvement in premarket safety analytics.
The meeting objective is clear: to enhance premarket safety analytics through open dialogue and the adoption of standardized practices. This workshop represents a significant step towards a more unified and effective approach to ensuring drug safety before products reach the market.
