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<p>In April 2025, the U.S. Food and Drug Administration announced immediate steps toward replacing animal testing for drug evaluation with New Approach Methodologies (NAMs)—modern laboratory techniques mimicking human tissues. However, significant gaps exist between current regulatory frameworks and these technologies’ promise. We argue that specific comprehensive regulatory reforms will improve transition to human-relevant drug-evaluation methodologies, laying groundwork for digital twins, in silico trials, and transformative advances in precision medicine.</p>

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Advancing FDA New Approach Methodologies from animal models through digital twins

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月15日

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  • Ashley L. Eadie,
  • Holly Fernandez Lynch,
  • Naomi Scheinerman,
  • Ravi B. Parikh

摘要

In April 2025, the U.S. Food and Drug Administration announced immediate steps toward replacing animal testing for drug evaluation with New Approach Methodologies (NAMs)—modern laboratory techniques mimicking human tissues. However, significant gaps exist between current regulatory frameworks and these technologies’ promise. We argue that specific comprehensive regulatory reforms will improve transition to human-relevant drug-evaluation methodologies, laying groundwork for digital twins, in silico trials, and transformative advances in precision medicine.