Embracing human relevance: The FDA’s historic move beyond animal testing mandates

Abstract

Introduction: ushering in an era of humanrelevant drug evaluationOn April 10, 2025, the U.S. Food and Drug Administration (FDA) issued an announcement announcing that it will gradually eliminate animal testing requirements in the development of monoclonal antibodies (mAbs) and other drugs.The main contents of the new policy include (1) policy background and overall objectives; (2) new approach methodologies (NAMs) roadmap; (3) key alternative technologies; (4) regulatory incentives and implementation arrangements; and (5) cooperation mechanisms and follow-up plans.The initiative aims to reduce animal testing in preclinical safety studies using scientifically validated NAMs, including cell-based tests, organoids, organ-on-achips (OoCs), microphysiological systems (MPS), in silico tools and computational models, and real-world evidence (RWE) [1] .The 2025 "Roadmap to Reduce Animal Testing in Preclinical Safety Studies" adopts a phased approach, initially focusing on mAbs, and is expected to significantly reduce or replace animal studies within 3-5 years [2] .Animal model-based testing of mAbs has been particularly challenging, as species-specific targets and immunogenicity limit the predictive power of animal models.This underscores the need for NAMs in different therapeutic domains [3] .This article supports the FDA's policy shift as a scientifically necessary, ethically imperative, and technologically enabled evolution.It represents a move towards a drug development paradigm centered on human biology, promising accelerated development timelines, reduced costs, enhanced safety prediction, and ultimately, a "win-win for public health and ethics" [1] .For the Cell Organoid community, this transition highlights the critical role that advanced in vitro models, particularly organoid technologies, will play in shaping the future of medicine.

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