An industry perspective on the FDA modernization act 2.0/3.0: potential next steps for sponsors to reduce animal use in drug development

Carratt, Sarah A; Zuch de Zafra, Christina L; Oziolor, Elias; Rana, Payal; Vansell, Nichole R; Mangipudy, Raja; Vaidya, Vishal S

doi:10.1093/toxsci/kfae122

Cited by 59Animal testing and alternativesImmunotoxicology and immune responsesBiomedical Ethics and Regulation

An industry perspective on the FDA modernization act 2.0/3.0: potential next steps for sponsors to reduce animal use in drug development

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Carratt, Sarah A, Zuch de Zafra, Christina L, Oziolor, Elias, Rana, Payal, Vansell, Nichole R, Mangipudy, Raja, Vaidya, Vishal S·2025·Toxicological Sciences

DOI 10.1093/toxsci/kfae122

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Abstract

Pharmaceutical developers are encouraged to adopt the best practices of being purposefully thoughtful about the use of animals, seeking alternatives wherever possible. They should engage with health authorities to increase their familiarity with the methods, study designs, data outputs, and the context of use for new approach methodologies (NAMs). Although current state of technology does not yet provide adequate models to fully replace in vivo studies, many models are sufficiently good for an augmented approach that will enhance our understanding of in vitro to in vivo correlations and advance the long-term goal of reducing animal use through innovative NAMs. The goal of future nonclinical safety packages is to advance the utilization of such enabling technologies toward appropriate human risk characterization. Establishing confidence in NAMs is a critical first step. For example, sponsors may include both “traditional” and NAM-based nonclinical safety data in regulatory submissions to establish confidence with health authorities. In addition, regulators should create a “safe harbor” for hybrid nonclinical data packages to facilitate iterative learning, refinement, and implementation of NAM-based safety assessment strategies. Sponsors are urged to contribute to NAMs evolution through consortia participation, peer-reviewed publications, and documenting animal reduction in studies/programs, accelerating the eventual elimination of animal use in pharmaceutical development, as envisioned in the FDA Modernization Act 3.0.

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This focus aligns with broader regulatory developments, as reflected in the FDA Modernization Act 2.0 and 3.0, which promote the adoption of Organ-On-Chip (OOC) platforms and other New Approach Methodologies (NAMs) as alternatives to traditional animal testing.
“This focus aligns with broader regulatory developments, as reflected in the Food and Drug Administration (FDA) Modernization Act 2.0 and 3.0, which promote the adoption of Organ-On-Chip (OOC) platforms and other New Approach Methodologies (NAMs) as alternatives to traditional animal testing (Carratt et al., 2024; Zushin et al., 2023; Ahmed et al., 2023).”
From Mini-hearts for disease modeling and drug testing – process optimization versus biological functionality (2026) · cites this paper as Carratt et al., 2024

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Authors: Carratt, S. A., Zuch de Zafra, C. L., Oziolor, E., Rana, P., Vansell, N. R., Mangipudy, R., & Vaidya, V. S.
Affiliations: Pfizer (United States) (US)
Drug Safety Research and Development, Pfizer Research and Development , San Francisco, CA 94080,
Corresponding author: Vaidya, Vishal S
ORCID: Carratt, Sarah A
Oziolor, Elias
Rana, Payal
Mangipudy, Raja
Vaidya, Vishal S
Venue: Toxicological Sciences
Publisher: Oxford University Press (OUP)
Published: 2024-09-19
Volume: 203
Issue: 1
Pages: 28-34
ISSN: 1096-0929 (ISSN-L)
1096-6080
DOI: 10.1093/toxsci/kfae122
OpenAlex: W4402626359
Cited by: 59
References: 37
Citations by year: 2026: 33 · 2025: 26
FWCI: 32.14
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: academic.oup.com/pages/standard-publication-reuse-rights (vor)
Locations: Toxicological Sciences (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
Life Sciences › Immunology and Microbiology › Immunology › Immunotoxicology and immune responses
Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
Keywords: animal use reduction, new approach methodologies, nonclinical safety assessment, in vitro-in vivo correlation, regulatory submissions, alternatives to animal testing, drug development, regulatory science
MeSH terms: Drug Development, Animals, Animal Testing Alternatives, Drug Industry, Humans, United States, United States Food and Drug Administration

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An industry perspective on the FDA modernization act 2.0/3.0: potential next steps for sponsors to reduce animal use in drug development

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