FDA Modernization Act 3.0 Passed by the US House of Representatives
July 2026The FDA Modernization Act 3.0 requires FDA to replace regulatory references to animal testing with broader “nonclinical” testing approaches.
"The FDA now encourages human-relevant, NAM-based nonclinical approaches — one reason our engine pairs trusted methods with human-relevant tools.”
The FDA Modernization Act 3.0 requires FDA to replace regulatory references to animal testing with broader “nonclinical” testing approaches.
The guidance provides recommendations for general toxicology studies, with a primary focus on three-month toxicology studies for certain oncology pharmaceuticals. It recommends rodent studies only, or replacing three-month NHP studies with a weight-of-evidence risk assessment in certain cases.
The guidance provides a validation framework and general recommendations for using new approach methodologies (NAMs) in drug development.
The draft guidance provides recommendations to eliminate or reduce long-term primate toxicity studies for certain monoclonal antibodies, using alternative data sources such as computational models and human-relevant systems with a weight-of-evidence assessment.
This searchable, regularly updated inventory of specific drug development contexts shows exactly where alternative methods are acceptable.
The roadmap outlines FDA’s strategic, stepwise approach to reducing animal testing in preclinical safety studies through new approach methodologies, such as organ-on-a-chip systems, computational modeling, and advanced in vitro assays.