By FieldPulse Editorial · March 24, 2026
Tags: FDA, Policy, Pipeline
The FDA has published new guidance on New Approach Methodologies — including organ-on-a-chip and computational models — that aims to reduce regulatory uncertainty around non-animal testing and reflects a push to modernize drug development.
The FDA on Monday released new guidance addressing New Approach Methodologies, or NAMs — a category that includes organ-on-a-chip platforms, computational modeling, and other technologies designed to generate preclinical data without relying on traditional animal studies. The guidance is intended to reduce the regulatory uncertainty that has long made drug developers cautious about relying on NAMs, even when the science supported their use. Without clear agency guidance on what data would be acceptable and under what circumstances, companies have defaulted to animal testing simply because it r