Data / Federal rules / 2026-19350
Nonclinical Testing Terminology
The Food and Drug Administration published this final rule in the Federal Register on September 22, 2026. It takes effect on February 4, 2027. Comments are due by December 7, 2026.
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What the agency says
The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule that substitutes references to "animal" tests or studies with "nonclinical" tests or studies, adds a definition of the terms "nonclinical test" and "nonclinical study," and makes other comparable or conforming amendments in certain safety and reporting sections of its regulations. The direct final rule also substitutes "nonclinical" for "preclinical" and "in vitro" for consistency in terminology. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial changes in terminology that are not expected to affect industry practice and FDA anticipates no significant adverse comments. These amendments align with recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act (PHS Act) and are intended to remove an emphasis, in certain places, on the use of animal testing as the only scientific methodology to assess the safety of a drug in the nonclinical setting. These changes may also foster the development and use of scientifically valid new testing methodologies, potentially improving predictive accuracy of product safety testing while replacing, reducing, or refining animal use. The rule adds no new requirements.
Key facts
- Document number
- 2026-19350
- Type
- Final rule
- Action
- Direct final rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 22, 2026
- Takes effect
- February 4, 2027
- Comments due
- December 7, 2026
- Dates
- This rule is effective February 4, 2027. Either electronic or written comments on the direct final rule or its companion proposed rule must be submitted by December 7, 2026. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the direct final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule wi
- Docket
- Docket No. FDA-2026-N-5347
- Regulation ID (RIN)
- 0910-AJ27
- Code of Federal Regulations
- 21 CFR 312; 21 CFR 314; 21 CFR 315; 21 CFR 361; 21 CFR 601
- Topics
- Administrative practice and procedure; Biologics; Confidential business information; Drugs; Exports; Imports; Investigations; Labeling; Medical research; Prescription drugs; Radiation protection; Reporting and recordkeeping requirements; Safety
- Pages
- 17
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on administrative practice and procedure · Rules on biologics · Rules on confidential business information · Published in September 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.