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September 5, 2026Clinical Pharmacology & TherapeuticsOpen Access

Advances in New Approach Methodologies at FDA 's Division of Applied Regulatory Science

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Key result

NAMs offer human-relevant alternatives to traditional preclinical models for drug development and regulatory science.

Why the study?

New Approach Methodologies offer human-relevant alternatives to traditional preclinical models, prompting a review of recent advances in their development, validation, and regulatory application at FDA's Division of Applied Regulatory Science.

Design

Mini-review

Authors

KBKsenia BlinovaKCKimberly ChiuACAnik Chaturbedi

Discussion

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Overview

May support regulatory modernization with human-relevant models; leaves open prospective validation before clinical adoption.

Key Points

  • Review recent advances in New Approach Methodologies (NAMs) developed, validated, and applied by the FDA's Division of Applied Regulatory Science to modernize drug evaluation.
  • Evaluated computational (in silico) models, including quantitative systems pharmacology (QSP), (quantitative) structure-activity relationships ((Q)SAR), and multi-omics biomarker pipelines.
  • Assessed human cell-based (in vitro) platforms, including human-induced pluripotent stem cell (hiPSC) neural and cardiac systems, gastrointestinal transport assays, and microphysiological systems.
  • Computational models successfully predicted opioid overdose dynamics, toxicity profiles, and drug-drug interactions.
  • Human-derived cellular and microphysiological models accurately evaluated organ-specific drug permeability, transport, and proarrhythmia risks.
  • Integration of these tools into regulatory review frameworks supported safer, more human-relevant safety assessments while reducing reliance on animal testing.

Structured PICO

I
Intervention
New Approach Methodologies (NAMs) including in silico (QSP, QSAR, multi-omics) and in vitro (hiPSC-derived neural networks, MPS, gastrointestinal models, cardiac ion channel and hiPSC-CM MEA assays) models
C
Comparator
Traditional preclinical models (animal studies)
O
Outcome
Development, validation, and regulatory application of NAMs

New Approach Methodologies (NAMs) are increasingly integrated into FDA regulatory frameworks to provide human-relevant alternatives to traditional animal testing for drug safety and efficacy.

Cite This Study

Blinova et al. (2026) reported a review. New Approach Methodologies (NAMs) vs. traditional preclinical models was evaluated. New Approach Methodologies (NAMs), including in silico and in vitro models, offer human-relevant alternatives to traditional preclinical models for drug development and regulatory science.

synapsesocial.com/papers/6a9bd48c6b95aff0620ec56fhttps://doi.org/10.1002/cpt.70472
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