FDA advances regulatory use of New Approach Methodologies (NAMs)

The release of this document represent another major milestone in the implementation of the FDA’s roadmap to reducing animal testing, and reflects the FDA’s commitment to moving away from using animal testing as the default method for gaining drug safety information.

The guidance provides a general framework for drug developers on how to design, validate, and report the use of New Approach Methodologies (NAMs)—including computational models, human cell-based systems, and other advanced in vitro and in silico approaches—within drug development programs. It aims to support the generation of scientifically robust evidence while reducing reliance on traditional animal testing.

A key focus of the document is the establishment of scientific principles for study design and reporting, alongside a validation framework to ensure that NAMs are “fit for purpose” in regulatory submissions. This includes considerations on how such methods can reliably predict human responses and be integrated into nonclinical safety assessments.

By encouraging the use of NAMs, FDA aims to increase efficiency and potentially accelerate development timelines.

👉 Access the full guidance