FDA Releases Retrospective Report on Roadmap to Reduce Animal Testing

By: Galen Cobb
Friday, May 15, 2026
On April 20, the U.S. Food and Drug Administration (FDA) released Reducing Animal Testing in Nonclinical Studies: Year One Progress and the Path Forward, a one-year follow-up to its 2025 Roadmap to Reduce Animal Testing. The report highlights key accomplishments toward the Roadmap's goals and signals the agency's continued commitment to advancing new approach methodologies (NAMs) in nonclinical research, including making the Innovative Science and Technology Approaches for New Drugs (ISTAND) Program permanent, establishing a NAMs Acceptability Database to improve transparency on accepted approaches, updating monoclonal antibody guidance to eliminate requirements for six-month nonhuman primate studies, and qualifying the first artificial intelligence (AI) drug development tool for use in clinical trials.

While the report's framing emphasizes the readiness of NAMs for broader implementation, the underlying materials from the listed examples present a more nuanced picture, acknowledging the continued need for animal models across many drug classes and disease areas. FASEB will continue to monitor the FDA's progress on the Roadmap and advocate for a measured, evidence-based approach to changes in nonclinical research methodology.