Comment from Alternatives Research & Development Foundation

The Alternatives Research & Development Foundation (ARDF) is a non-profit scientific funding organization that promotes the development and implementation of alternative methods with the aim of reducing and replacing the use of animals in research. We appreciate the opportunity to comment on the US Food and Drug Administration’s (FDA) draft guidance “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products” (Docket No. FDA-2026-D-2839). ARDF supports the FDA’s efforts to enhance nonclinical safety assessments by incorporating integrated knowledge-based risk assessments to ensure that decisions are based on the most up-to-date scientific evidence while reducing the reliance on animal studies. Decades of experience in assessing the safety of biologics along with advances in computational methods and human-based in vitro systems, have significantly expanded the scientific evidence available to inform regulatory decisions. The draft guidance represents a thoughtful, considered, and scientifically justified shift in regulatory practice, allowing complementary sources of evidence to collectively reduce uncertainty while maintaining confidence in nonclinical safety assessments. This evidence-based approach benefits patients, sponsors, and researchers, while supporting the broadly shared goal of reducing unnecessary animal studies. We encourage FDA to continue demonstrating leadership in the implementation of approaches to streamline nonclinical safety assessments, including weight-of-evidence (WoE) risk assessments with supplementary and supporting evidence from New Approach Methodologies (NAMs). Of course, any additional information to support implementation of this guidance, especially the inclusion of successful case studies of WoE assessments, would be a welcome addition that would further strengthen the usefulness of this guidance. We hope that FDA will regularly review this guidance to ensure it reflects emerging scientific knowledge and incorporates insights gained through its implementation. We also hope that the benefits achieved by this guidance will encourage similar efforts for other therapeutic areas. Finally, we applaud FDA for its commitment to supporting a more efficient, evidence-based regulatory framework while maintaining its ultimate priority to patient safety.