FDA Draft Guidance on New Approach Methodologies in Drug Development

Detected March 18th, 2026

Summary

The FDA has issued draft guidance for industry on the use of New Approach Methodologies (NAMs) in drug development. The guidance provides a validation framework and recommendations to improve human relevance and reduce animal testing, encouraging NAMs in regulatory submissions.

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What changed

The Food and Drug Administration (FDA) has released a draft guidance document titled "General Considerations for the Use of New Approach Methodologies in Drug Development." This guidance, issued by the Center for Drug Evaluation and Research (CDER), aims to provide drug developers with a framework for validating and using NAMs, which are intended to improve human relevance and reduce reliance on animal testing. The document encourages the incorporation of NAMs into regulatory submissions, particularly when they enhance the predictivity of nonclinical studies for clinical trial safety.

This draft guidance is open for public comment, with submissions accepted online or in writing to Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All comments should reference docket number FDA-2025-D-6131. While the guidance itself is non-binding, drug manufacturers should review its recommendations for incorporating NAMs into their development processes to align with FDA priorities and potentially improve study outcomes.

What to do next

Review draft guidance on NAMs for drug development
Submit comments to FDA docket FDA-2025-D-6131 by the specified deadline

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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Drug Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “General Considerations for the Use of New Approach Methodologies in Drug Development.” The purpose of this draft guidance is to provide drug developers with a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development.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.