In a significant development aligning closely with NAVS’ mission, the U.S. Food and Drug Administration (FDA) recently announced a landmark plan to phase out animal testing requirements for monoclonal antibodies and other drugs. This new approach seeks to replace outdated animal tests with more effective, human-relevant research methods, emphasizing improved drug development safety, efficiency, and ethical standards.
Under the new guidelines, the FDA will encourage pharmaceutical developers to shift toward innovative, non-animal testing methods known as New Approach Methodologies (NAMs). These include artificial intelligence (AI)-based computational modeling, human organoids, and “organ-on-a-chip” technologies to generate insights that, in many cases, better reflect human biology and predict outcomes more accurately than traditional animal tests. The agency has stated this transition will not only accelerate drug safety evaluations but also lower overall research costs, ultimately benefiting patients with more accessible medicines.
FDA Commissioner Martin A. Makary described this shift as a “paradigm shift” that “holds promise to accelerate cures,” indicating a strong commitment to modernizing regulatory practices in alignment with scientific advancements. The agency also anticipates that thousands of animals—including dogs and primates—could eventually be spared from testing annually as these advanced methods become standard practice.
For decades, NAVS and other animal welfare and science advocacy organizations have promoted the use of advanced alternatives to animal experimentation, highlighting their ability to produce more relevant and predictive data for human health. The FDA’s announcement represents a long-awaited recognition of these arguments and an important step forward in the nationwide movement toward humane science.
Encouragingly, the Environmental Protection Agency (EPA) may soon revisit its plan to phase out animal testing. That plan would reinstate targets to reduce mammal testing by 30% by 2025 and eliminate it entirely by 2035. The EPA currently uses tens of thousands of vertebrate animals each year to assess chemical toxicity. Reinstating a clear, time-bound strategy to replace these tests would be a major step toward modernizing chemical safety assessments, reducing animal suffering, and encouraging the adoption of innovative tools in toxicology.
Taken together, these developments at the FDA and EPA signal growing federal momentum toward more ethical, science-driven approaches. While these efforts mark real progress, achieving a full transition away from animal-based research will require continued investment, policy change, and public support. For NAVS, the goal remains clear: to replace all animal use in biomedical research with human-relevant methods that better serve both science and society.
NAVS is deeply grateful to our supporters, whose advocacy and generosity help make this work possible—from funding early-career scientists exploring non-animal methods, to pressing agencies for accountability and transparency. As regulatory agencies move forward, NAVS will continue to monitor their progress, contribute to stakeholder discussions, and ensure that our community remains informed and engaged. With your continued partnership, we are advancing a future where innovation and compassion go hand in hand.
