U.S. FDA Amends Regulations for Non-Animal Drug Testing

The U.S. Food and Drug Administration today issued a direct final rule that updates its regulations to clarify that non-animal methods can be used where appropriate for testing the safety of drugs and biological products intended for human use before they’re tried in humans. The update reflects advances in science and technology that have expanded the range of testing options available in human drug development, including methods using human cells, organs-on-chips, computer models and other advanced technologies. “This new rule supports the Trump Administration’s push to explore ways to complement, or where appropriate, replace animal studies with methods that may better predict how medicines will actually affect people,” said Acting FDA Commissioner of Food and Drugs, Kyle Diamantas, J.D. “It gives scientists and drug developers greater flexibility to use the testing approach that best addresses their scientific question. Our goal is not to replace one rigid approach with another. It is to support rigorous, modern science — including animal studies when they remain appropriate and validated alternatives when they can provide the evidence needed to protect patients.” The rule replaces terms like “animal tests” and “animal studies” with the terms “nonclinical tests” and “nonclinical studies.” Related terms, including “preclinical” and “in vitro,” are also replaced. The rule defines “nonclinical test” and “nonclinical study” in line with the Food and Drug Omnibus Reform Act of 2022 (FDORA). The law recognizes newer methods that do not use animals and traditional animal studies as possible ways to provide the evidence needed to begin studies in people. The rule removes language that could suggest that animal testing is the only acceptable way to generate safety information for regulatory decisions in products intended for human use. It does not eliminate or prohibit animal studies, change evidentiary standards or impose new costs or requirements on drug developers. To demonstrate their practical application, the FDA also launched a database featuring specific uses of New Approach Methodologies (NAMs) . The initial release includes 25 examples drawn from publicly available FDA review materials. The new rule and database are among several actions that the Department of Health and Human Services, including the FDA, is taking to advance drug development using NAMs, which are innovative testing methods that may better reflect human biology. Developers may use NAMs to generate safety information when the methods are adequately validated and appropriate for the product and regulatory question. These actions are in line with Pillar 1 — Innovation and Global Leadership — of the FDA’s Public Health Pillars . By formally recognizing a broader range of scientific approaches, the FDA is keeping pace with emerging technologies and strengthening the agency’s leadership in regulatory science. Encouraging the use of NAMs also complements Operation TrialBlazer , the Department of Health and Human Services initiative to modernize clinical research and accelerate the development of life-saving treatments. Clearer terminology and regulatory expectations can reduce avoidable uncertainty as sponsors develop nonclinical evidence and prepare applications to begin clinical trials. The agency is inviting the public, including clinicians, parents, caregivers, the scientific community, industry, and others, to comment on the rule. For additional information, see the Federal Register notices announcing the direct final rule, the companion proposed rule , and the comment period. If the FDA receives significant adverse comments on the direct final rule, the agency will withdraw it and continue rulemaking through the standard notice-and-comment process using the companion proposed rule. Publishing both simultaneously ensures the rulemaking can proceed efficiently under either scenario. Media: FDA Request for Comment 202-690-6343 Consumer: 888-INFO-FDA The FDA, a