FDA Alternative Methods Working Group

In 2019, FDA chartered 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 2020 and 2021, the working group coordinated an internal webinar series on alternative methods that provided test method developers the opportunity to present their new methods to FDA scientists.

The 2021 FDA report, Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science, outlined areas 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 of those priority areas was “Advancing Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing.”