FDA Alternative Methods Working Group
For over four years, FDA has maintained an Alternative Methods Working Group with representatives from all of FDA. The goals of this working group are to:
- Strengthen FDA’s long commitment to promoting the development and use of new technologies and to reduce animal testing.
- Discuss new alternative in vitro/in silico/in vivo methods across FDA.
- Interact with federal government partners and other global stakeholders to facilitate discussion and development of draft performance criteria for such assays.
During 2022 and 2023, the working group continued to coordinate an internal webinar series on alternative methods that provided test method developers the opportunity to present their new methods to FDA scientists. The group also updated FDA webpages on alternative methods to provide a more comprehensive and user-friendly resource for this information. Two 2022 reports are available from these pages:
- The Focus Areas of Regulatory Science (FARS) report, updated in 2022, outlines areas FDA has identified as needing continued targeted investment in regulatory science research to foster the development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. One focus area is novel technologies to improve predictivity of nonclinical studies and replace, reduce, and refine animal testing.
- The November 2022 report, Successes and Opportunities in Modeling & Simulation for FDA, elucidates in part how and where modeling and simulation are used across FDA.