Advancing Regulatory Adoption of New Approach Methodologies

IF 4.9 2区医学 Q1 PHARMACOLOGY & PHARMACY

Clinical Pharmacology & Therapeutics Pub Date : 2026-10-16 Epub Date: 2026-09-18 DOI:10.1002/cpt.70482

Jeffry Florian, Kimberly Chiu, Rebecca Racz, C. Lee Elmore, Shirley K. Seo, Ksenia Blinova, Wendy W. Wu, Rodney Rouse

引用次数: 0

Abstract

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has a long history advancing new approach methodologies (NAMs). In collaboration with external organizations and other regulatory agencies, FDA supports continued development of NAMs for regulatory use. Within CDER, qualification programs and interdisciplinary review teams provide opportunities for increased regulatory impact of NAMs. CDER also continues to provide regulatory input to NAMs developers and end users to advance regulatory acceptance of NAMs.

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推动监管机构采用新方法。

美国食品和药物管理局（FDA）药物评估和研究中心（CDER）在推进新方法方法（NAMs）方面有着悠久的历史。在与外部组织和其他监管机构的合作中，FDA支持继续开发用于监管的NAMs。在CDER内部，资格认证项目和跨学科审查团队为NAMs增加监管影响提供了机会。CDER还继续向NAMs开发商和最终用户提供监管投入，以促进NAMs的监管接受。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Pharmacology & Therapeutics 医学-药学

CiteScore

12.70

自引率

7.50%

发文量

290

审稿时长

2 months

期刊介绍： Clinical Pharmacology & Therapeutics (CPT) is the authoritative cross-disciplinary journal in experimental and clinical medicine devoted to publishing advances in the nature, action, efficacy, and evaluation of therapeutics. CPT welcomes original Articles in the emerging areas of translational, predictive and personalized medicine; new therapeutic modalities including gene and cell therapies; pharmacogenomics, proteomics and metabolomics; bioinformation and applied systems biology complementing areas of pharmacokinetics and pharmacodynamics, human investigation and clinical trials, pharmacovigilence, pharmacoepidemiology, pharmacometrics, and population pharmacology.