The US Food and Drug Administration has issued a draft guidance to help drug developers validate new approach methodologies (NAMs) as an alternative to animal testing, and to bring safe, effective drugs sooner to market based on human-centric data. 

This marks another major milestone in the implementation of the FDA’s roadmap to ending the use of animal testing as the default method for gaining drug safety information.

Under the FDA’s regulations, drug sponsors must submit non-clinical pharmacology and toxicology data before the investigational drugs can proceed to clinical trials. While many studies have traditionally depended on animal testing, the Center for Drug Evaluation and Research (CDER) routinely reviews data from NAMs when the methodology demonstrates reliability and scientific validity.

“Technological advances are allowing us to move beyond animal testing in drug development, which has a poor track record of predicting safety and efficacy in humans,” said FDA Commissioner Marty Makary. “This guidance will facilitate the adoption of modern alternatives to animal testing in regulatory submissions.”

Examples of NAMs include innovative testing such as complex and two-dimensional in-vitro (laboratory) studies; three-dimensional models such as organoids, spheroids and organs on chips; chemical reactivity studies; computer simulations or in-silico modelling; and studies using “phylogenetically lower” animals such as zebrafish or C elegans. There are now several examples of validated NAMs outperforming unvalidated animal models in predicting human responses to drugs. NAMs can identify toxicities, demonstrate how the investigational drug works, improve predictivity of non-clinical studies, and enhance the safety of future clinical trials.

While the guidance provides general validation considerations for NAMs used in drug development, it does not address specific methodologies or drug discovery applications. FDA encouraged drug developers to consult with the appropriate FDA review division when considering NAMs, particularly for indication-, disease-, organ-, and endpoint-specific applications.

(Source: USFDA)

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Published on March 23, 2026