FDA Updates Regulations to Advance
Innovative Alternatives to Animal Testing

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The U.S. Food and Drug Administration (FDA) has issued a direct final rule updating its regulations to clarify that non-animal methods can be used, where appropriate, to test the safety of drugs and biological products before they are studied in humans. The rule reflects advances in science and technology, including methods using human cells, organs-on-chips, and computer models. The agency also launched a database featuring specific uses of New Approach Methodologies (NAMs), with an initial release of 25 examples drawn from publicly available FDA review materials.

Key Highlights

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• The direct final rule replaces terms such as “animal tests” and “animal studies” with “nonclinical tests” and “nonclinical studies,” defining the new terms in line with the Food and Drug Omnibus Reform Act of 2022 (FDORA).
• The rule removes language that could suggest animal testing is the only acceptable way to generate safety information; it does not eliminate or prohibit animal studies, change evidentiary standards, or impose new costs or requirements on drug developers.
• The FDA launched a database of New Approach Methodologies (NAMs), with an initial release of 25 examples drawn from publicly available FDA review materials.
• The actions are part of broader efforts by the Department of Health and Human Services to advance drug development using NAMs, complementing Operation TrialBlazer, an initiative to modernize clinical research.
• The FDA is inviting public comment on the rule; if significant adverse comments are received on the direct final rule, the agency will withdraw it and continue through a companion proposed rule under the standard notice-and-comment process.

Statements

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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. 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.

• Acting FDA Commissioner of Food and Drugs, Kyle Diamantas, J.D.

About the Organizations

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The U.S. Food and Drug Administration is the federal agency within the Department of Health and Human Services responsible for protecting public health by assuring the safety, effectiveness, and security of human and veterinary drugs, biological products, medical devices, the food supply, cosmetics, and tobacco products.

Learn More

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FDA Press Announcement: FDA Updates Regulations to Advance Innovative Alternatives to Animal Testing
Nonclinical Testing Terminology Direct Final Rule (Federal Register)