{"title":"Commentary on FDA`s Shift from Animal Testing and Implications for Drug Attrition - The Time to Act is Now.","authors":"","doi":"10.1016/j.yrtph.2025.105896","DOIUrl":null,"url":null,"abstract":"<p><p>The U.S. FDA's recent policy shift toward accepting non-animal alternatives for investigational new drug (IND) applications marks a pivotal moment in regulatory science. While full replacement of animal testing will take time, the high and rising attrition rates in pharmaceutical R&D demand immediate action. One of the clearest opportunities lies in the prediction of drug-induced liver injury (DILI), a key contributor to late-stage failures. Human-relevant new approach methodologies (NAMs), such as microphysiological systems and in vitro functional assays, offer enhanced mechanistic insight and population-level predictivity. This commentary explores the implications of the FDA's new policy and argues for accelerated adoption of NAMs in targeted domains where human biology-based systems can outperform traditional animal models.</p>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":" ","pages":"105896"},"PeriodicalIF":3.0000,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regulatory Toxicology and Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.yrtph.2025.105896","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, LEGAL","Score":null,"Total":0}
引用次数: 0
Abstract
The U.S. FDA's recent policy shift toward accepting non-animal alternatives for investigational new drug (IND) applications marks a pivotal moment in regulatory science. While full replacement of animal testing will take time, the high and rising attrition rates in pharmaceutical R&D demand immediate action. One of the clearest opportunities lies in the prediction of drug-induced liver injury (DILI), a key contributor to late-stage failures. Human-relevant new approach methodologies (NAMs), such as microphysiological systems and in vitro functional assays, offer enhanced mechanistic insight and population-level predictivity. This commentary explores the implications of the FDA's new policy and argues for accelerated adoption of NAMs in targeted domains where human biology-based systems can outperform traditional animal models.
期刊介绍：
Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health.
Types of peer-reviewed articles published:
-Original research articles of relevance for regulatory aspects covering aspects including, but not limited to:
1.Factors influencing human sensitivity
2.Exposure science related to risk assessment
3.Alternative toxicological test methods
4.Frameworks for evaluation and integration of data in regulatory evaluations
5.Harmonization across regulatory agencies
6.Read-across methods and evaluations
-Contemporary Reviews on policy related Research issues
-Letters to the Editor
-Guest Editorials (by Invitation)
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
