Docket Number: FDA-2025-D-6131 Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The purpose of this draft guidance is to provide drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development. Although animal toxicity studies have proved to be a critical method to identify potential risks to human health, finding ways to improve human relevance while reducing the use of animals by developing reliable NAMs furthers an important Center for Drug Evaluation and Research (CDER) priority to move away from reliance on animal testing. The recommendations in this draft guidance are intended to highlight scientific principles of study design and reporting that can be applied broadly and flexibly in the validation of NAMs used in drug development. This draft guidance is not intended to address specific NAMs and does not address the use of NAMs in drug discovery; rather, it encourages the use of NAMs in regulatory submissions, especially when they improve the predictivity of nonclinical studies for increased safety in clinical trials.