New Approach Methodologies (NAMs)
The FDA is implementing a shift toward New Approach Methodologies (NAMs) to reduce, replace, or refine traditional animal testing in favor of human-relevant safety evaluation methods.
Biopharmaceutical manufacturers, toxicologists, and regulatory professionals involved in drug safety evaluation and nonclinical study design.
This transition suggests a regulatory preference for predictive models that more closely align with human physiology. It may eventually alter the evidentiary requirements for Investigational New Drug (IND) and Biologics License Application (BLA) submissions. Operational shifts may be required to validate and implement these advanced methods within existing development pipelines.
Sponsors should evaluate existing nonclinical programs for opportunities to integrate NAMs. Regulatory teams should monitor for forthcoming technical standards or specific validation requirements for human-relevant methodology to ensure data acceptability in future filings.
The FDA is leading a transformative shift in drug safety evaluation—reducing, replacing or refining animal testing with advanced, human-relevant methods that better predict how medicines work in people.
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