FDA modernization act 2.0: transitioning beyond animal models with human cells, organoids, and AI/ML-based approaches
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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 Zushin et al., 2023
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- Authors
- Zushin, P.-J. H., Mukherjee, S., & Wu, J. C.
- Affiliations
- Stanford Medicine (US)
- Corresponding author
- Wu, Joseph C.
- Venue
- Journal of Clinical Investigation
- Published
- 2023-11-01
- Volume
- 133
- Issue
- 21
- ISSN
- 0021-9738 (ISSN-L)
- 1558-8238
- PMC
- PMC10617761
- OpenAlex
- W4388079620
- Cited by
- 347
- References
- 18
- Citations by year
- 2026: 147 · 2025: 140 · 2024: 57 · 2023: 2 · 2022: 1
- FWCI
- 105.36
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal of Clinical Investigation (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- National Institutes of Health (HL145676)
- Stanford Bio-X
- National Heart, Lung, and Blood Institute (R01HL141371, R01HL145676, R01HL141851, R01HL130020, R01HL146690)
- National Institute of Biomedical Imaging and Bioengineering (T32EB009035)
- Topics
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Physical Sciences › Engineering › Biomedical Engineering › 3D Printing in Biomedical Research
- Keywords
- animal models, human cells, organoids, artificial intelligence, machine learning, drug regulation, alternative models, preclinical testing
- MeSH terms
- Animals, Humans, Organoids, United States, United States Food and Drug Administration, Drug Approval, Models, Animal
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