FDA reports and presentations on progress in advancing alternatives
In 2021, FDA published “Advancing New Alternative Methodologies at FDA,” which provided updates on activities to advance development of alternatives to animal use and their application to regulatory decision-making. The report was developed by the FDA Alternative Methods Working Group to highlight the progress made by FDA scientists in laying the groundwork to integrate alternatives to animal testing into FDA regulatory programs. Two reports issued in 2022 expanded on topics discussed in the report:
- The 2022 “Update to the Focus Areas of Regulatory Science (FARS) Report” outlines topics FDA has identified as needing continued targeted investment. FDA reviewed each of the focus areas from the 2021 report, and this document provides important updates to the examples highlighted in the report.
- A November 2022 report on “Successes and Opportunities in Modeling & Simulation for FDA” was prepared by the FDA Modeling and Simulation Working Group. The report:
- Elucidates how and where modeling and simulation is used across FDA, and the type and purpose of modeling and simulation used.
- Presents a selection of modeling and simulation case studies from across nearly all FDA centers, which demonstrate how modeling and simulation is playing a tangible role in FDA fulfilling its mission.
- Identifies opportunities for FDA to better harness modeling and simulation in upcoming years by embracing computational advances and new (and big) data streams to develop improved public health solutions.
FDA scientists also gave presentations on activities to advance alternatives at several public meetings during 2022 and 2023. Details of these presentations and presentation slides are available on the FDA website.