FDA Proposes Axing 'Animal' from Drug Testing Regulations
Published Date: 9/22/2026
Proposed Rule
Summary
The FDA wants to update its rules by swapping out the word “animal” tests for “nonclinical” tests to better reflect modern science. This change affects drug safety testing rules, encourages new testing methods that might use fewer animals, and doesn’t add any new costs or requirements. Anyone interested can comment on these changes until December 7, 2026.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Regulatory Terms Switched to “Nonclinical”
FDA will replace terms like “animal test,” “animal study,” “preclinical,” and “in vitro” with the word “nonclinical” across drug and biological product rules in 21 CFR parts 312, 314, 315, 361, and 601 and will add regulatory definitions for “nonclinical test” and “nonclinical study.” The agency says these changes align with statute and add no new requirements or costs.
NAMs and Other Methods Explicitly Included
FDA explicitly defines “nonclinical test/study” to include methods such as cell-based assays, organ chips and microphysiological systems, computer modeling (in silico), in chemico methods, bioprinting, and animal tests, and indicates that pharmacology, toxicology, and pharmacokinetic data in INDs, NDAs, and BLAs may come from these nonclinical sources. FDA says it will review such nonanimal nonclinical data to determine if they adequately support clinical studies.
No New Testing Costs Or Requirements
FDA states the proposed terminology changes would add no new requirements on industry and are expected to generate no costs; the Agency characterizes the rule as an Executive Order 14192 deregulatory action. The rule is presented as allowing broader nonclinical methods without increasing submission burdens.
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Key Dates
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