FDA updates terminology to clarify animal testing is not required for all drugs

The Food and Drug Administration (FDA) has issued a direct final rule regarding “Nonclinical Testing Terminology” to clarify that animal testing is not a mandatory requirement for all drugs or biological products. The new rule replaces terms such as “preclinical” and “in vitro” with the adjective “nonclinical” to align with a 2022 law that recognizes non-animal studies as valid methods for providing evidence to begin human studies.

Acting Commissioner of Food and Drugs Kyle Diamantas stated the change provides scientists and drug developers more flexibility to use the testing approaches that best suit their specific scientific questions. The agency noted it is not prohibiting animal studies or changing evidentiary standards, but rather removing language that suggested animal testing was the only acceptable way to generate safety information.

Additionally, the FDA is launching a database for “New Approach Methodologies” (NAMs), which includes AI-powered models, human organ-on-a-chip systems, and real-world data. Animal welfare organizations, including the Center for a Humane Economy and Animal Wellness Action, have praised the move, describing the previous terminology as “archaic.”