New policy signals major shift toward human-relevant science and away from outdated animal testing
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) today released a sweeping new draft guidance, “General Considerations for the Use of New Approach Methodologies (NAMs) in Drug Development,” marking a pivotal step toward replacing animal testing with more predictive, human-relevant methods.
The guidance encourages drug developers to incorporate New Approach Methodologies—including advanced computational models, human cell-based systems, and organ-on-chip technologies—into regulatory submissions, and signals that such approaches can serve as primary evidence in evaluating drug safety.
“This marks one more step toward a future making animal testing the exception rather than the rule in drug development,” said Wayne Pacelle, president of the Center for a Humane Economy and Animal Wellness Action. “For decades, drug development has relied on animal testing that is slow, costly, and often fails to predict human outcomes. Under the leadership of Dr. Marty Makary, FDA is now clearly signaling that the future lies in modern, human-relevant science—and that transition is already underway.”
FDA leadership underscored the significance of the shift. “Technological advances are allowing us to move beyond animal testing in drug development, which has a poor track record of predicting safety and efficacy in humans,” said FDA Commissioner Dr. Marty Makary. “This guidance will facilitate the adoption of modern alternatives to animal testing in regulatory submissions.”
These statements reflect a clear acknowledgment at the highest levels of the agency that animal-based models are scientifically outdated, and that more predictive, human-relevant approaches are ready for broader regulatory use.
The draft guidance also reflects the implementation of the FDA Modernization Act 2.0, enacted in 2022, which removed the longstanding statutory requirement that new drugs be tested in animals prior to human trials. By explicitly referencing this authority, FDA is signaling that sponsors can—and should—leverage scientifically valid non-animal methods in place of traditional animal studies.
“This guidance reflects a growing scientific consensus: animal models are not reliable predictors of human biology,” said Tamara Drake, director of research and regulatory policy at the Center for a Humane Economy. “Congress cleared the way with FDA Modernization Act 2.0, and now FDA is putting that vision into practice. By elevating New Approach Methodologies as credible and, in some cases, preferred forms of evidence, the agency is helping to unlock faster, safer drug development while sparing countless animals from unnecessary suffering.”
The agency’s framework emphasizes the importance of using methods that are “fit for purpose,” encouraging sponsors to select tools that are mechanistically relevant and predictive of human outcomes. It also promotes integrated approaches that combine NAMs with existing data to strengthen regulatory decision-making.
“Modern science has reached a point where we can model human disease and drug response with far greater precision than animal systems ever allowed,” said Dr. Zaher Nahle, senior scientific advisor for the Center for a Humane Economy and Animal Wellness Action. “This guidance provides a scientific and regulatory foundation for accelerating the transition to these superior methods. It is a win for patients, a win for innovation, and a win for animals.”
The FDA action comes the same day the National Institutes of Health (NIH) announced a $150 million investment in human-based research designed to reduce reliance on animal models, including funding to develop and standardize new approach methodologies across the research ecosystem.
“NIH’s investment is an important signal that the future of biomedical research is increasingly human-based,” Drake added. “Continued progress will depend on sustained funding, clear benchmarks, and a coordinated strategy to expand the use of these modern methods across the research enterprise.”
“With FDA charting a clear course toward non-animal methods, there is an opportunity for NIH to further align its broader research portfolio with this direction,” Pacelle added. “Prioritizing innovative, human-relevant science will help accelerate medical progress while ensuring the most effective use of taxpayer resources.”
The FDA is accepting public comments on the draft guidance before finalizing the policy.