14:I[94367,["/_next/static/immutable/chunks/4370mg0uq-myq.js","/_next/static/immutable/chunks/0q7ni_ir0mogv.js","/_next/static/immutable/chunks/0q9_4lzwjwc3f.js","/_next/static/immutable/chunks/1p8rnjckwz-06.js","/_next/static/immutable/chunks/3zikwth1q5z_-.js","/_next/static/immutable/chunks/0eigul57_x91p.js","/_next/static/immutable/chunks/3r0kxtkfnobr8.js","/_next/static/immutable/chunks/260mvqou7a4l3.js","/_next/static/immutable/chunks/14bkwvgoktej3.js"],"NewsDetailPage"] 15:Tceb,

Drug development traditionally uses animal studies to generate safety information before a medicine is tested in humans. However, advances in biotechnology and computational science have introduced New Approach Methodologies (NAMs), including human-cell-based testing, organs-on-chips, and computer models. The U.S. Food and Drug Administration (FDA) has now updated its regulations to clarify that appropriate, validated non-animal methods can also be used to support safety assessments for drugs and biological products intended for human use.

The FDA issued a direct final rule on September 21, 2026, updating terminology and regulatory language related to nonclinical testing. The change is intended to provide drug developers and scientists with greater flexibility in selecting testing approaches that are scientifically appropriate for the product and regulatory question.

Under the new rule, terms such as “animal tests” and “animal studies” are replaced with broader terms such as “nonclinical tests” and “nonclinical studies.” The FDA said the updated terminology reflects the Food and Drug Omnibus Reform Act of 2022, which recognizes both traditional animal studies and newer methods that do not use animals as potential sources of evidence before clinical studies in humans.

The regulatory update does not prohibit or eliminate animal studies. It also does not change existing evidentiary standards or introduce new costs or requirements for drug developers. Instead, it removes wording that could imply that animal testing is the only acceptable approach for generating safety information for regulatory decisions. The FDA has also launched a New Approach Methodologies (NAMs) Database of Use Case Examples to demonstrate how these methods can be applied in drug development. The initial database contains 25 examples based on publicly available FDA review materials. Developers may use NAMs when the methods are adequately validated and appropriate for the specific product and regulatory question.

The agency said the regulatory changes are part of broader efforts by the U.S. Department of Health and Human Services and the FDA to modernize drug development and clinical research. The FDA noted that some NAMs may better reflect aspects of human biology and could help reduce uncertainty when developers prepare nonclinical evidence for clinical trial applications. The FDA is inviting comments on the new rule from clinicians, caregivers, researchers, industry representatives, and other stakeholders. If significant adverse comments are received on the direct final rule, the FDA may withdraw it and continue the rulemaking process through its accompanying proposed rule.

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