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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 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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Metadata
- 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
- 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 › Nursing › Issues, ethics and legal aspects › 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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