Full Title Name:  Roadmap to Reducing Animal Testing in Preclinical Safety Studies

Summary: Executive Summary: This roadmap outlines a strategic, stepwise approach for FDA to reduce animal testing in preclinical safety studies with scientifically validated new approach methodologies (NAMs), such as organ-on-a-chip systems, computational modeling, and advanced in vitro assays. By partnering with federal agencies like NIH and VA through ICCVAM, FDA can accelerate the validation and adoption of these human-relevant methods, improving predictive accuracy while reducing animal use. This transition will enhance public health by streamlining drug development and ensuring safer therapies reach patients faster, while positioning FDA as a global leader in modern regulatory science and innovation.