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Nonclinical Testing Terminology
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, Agency, or we) is proposing to substitute references to "animal" tests or studies with "nonclinical" tests or studies, add a definition of the terms "nonclinical test" and "nonclinical study," and make other comparable or conforming amendments in certain safety and reporting sections of its regulations. The proposed rule would also substitute "nonclinical" for "preclinical" and "in vitro" for consistency in terminology. These proposed 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 proposed rule would add no new requirements.
- Document type
- Proposed Rule
- Federal Register document number
- 2026-19349
- Published
- Sep 22, 2026
- Action
- Proposed rule.
- Docket
- FDA-2026-N-5347
- Comments posted on Regulations.gov (at last check)
- 111
- RIN
- 0910-AJ27
- CFR parts
- 21 CFR 312, 21 CFR 314, 21 CFR 315, 21 CFR 361, 21 CFR 601
- DATES section (from the document)
- Either electronic or written comments on the proposed rule or its companion direct final rule must be submitted by December 7, 2026. If FDA receives any timely significant adverse comments on this proposed rule or the direct final rule with which this proposed rule is associated, we will publish a document in the Federal Register withdrawing the direct final rule within 30 days after the comment period ends, and we will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures.
- Topics (auto-tagged)
- Clinical Vaccines / biologics
Source: Federal Register API, document 2026-19349. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.