FDA advances commitment to moving beyond animal testing

The draft guidance, ‘General Considerations for the Use of New Approach Methodologies in Drug Development’, provides a validation platform and general recommendations for using new approach methodologies (NAMs) in drug development. The goal of this draft guidance is to highlight basic scientific principles for study designing and reporting that can be used flexibly when validating NAMs in drug development. It does not focus on any specific NAMs and does not cover their use in early drug discovery. Instead, it encourages the inclusion of NAMs in regulatory submissions, especially when they can make nonclinical studies more predictive and potentially improve safety in clinical trials.

The draft guidance establishes four core validation principles for NAMs:

• Context of Use: Clear definition of the NAM’s intended regulatory purpose
• Human Biological Relevance: Demonstration of how the NAM can assess toxicity
• Technical Characterisation: Establishment of scientific confidence through robust, reliable and reproducible methods
• Fit-for-Purpose: Assurance that the NAM can help in regulatory decision-making (for example, in drug review and potential approval)

The guidance focuses on the validation of NAMs and does not address the qualification of drug development tools (including NAMs). A key message from the guidance is that, based on the contextual weight of evidence, a new, non-validated NAM can be considered for review by the Center for Drug Evaluation and Research (CDER). The Agency encourages drug developers to engage with the appropriate review division to discuss the suitability of NAMs.

The release of this draft guidance represents another key milestone in the Agency’s commitment to moving away from animal testing as the default approach for assessing drug safety.

Comments can be submitted here by 18 May 2026.