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Product safetyFDAUnited StatesImports

Nonclinical Testing Terminology

22 September 2026

In plain English

FDA proposes to replace references to animal and preclinical tests with nonclinical terminology, add definitions of nonclinical test and study, and make conforming amendments to certain regulations.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
22 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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 wi
The full text is at the source

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