Laboratory Animal and Comparative Medicine ›› 2023, Vol. 43 ›› Issue (5): 472-481.DOI: 10.12300/j.issn.1674-5817.2023.083

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Implications on the Development of Animal Disease Models from FDA Modernization Act 2.0

Yinghan WAN1()(), Yexin GU2, Yunong YUAN2,3, Min TANG2()(), Li LU1()   

  1. 1.Shanghai Laboratory Animal Research Center, Shanghai 201203, China
    2.Cyberiad Biotechnology Ltd. , Shanghai 201312, China
    3.Faculty of Medicine and Health, University of Sydney, Sydney, 2006, Australia
  • Received:2023-06-20 Revised:2023-08-28 Online:2023-10-25 Published:2023-11-01
  • Contact: Yinghan WAN, Min TANG, Li LU


Laboratory animals are the foundational conditions and indispensable technical support in life science research and biomedical industry development. The scientific development of animal models of diseases is of great significance to biomedical research and industrial development. In light of the booming development of multiple emerging in vitro modelling technologies over the past decade, in 2022, the U.S. Senate unanimously passed the bill FDA Modernization Act 2.0. This bill rescinded the requirement for animal testing in investigating the safety and effectiveness of a drug—a federal mandate since 1938, and highlighted the potential of various invitro disease modeling approaches in future biomedical fields. This paper provides a comprehensive review of the latest advances and applications of in vitro disease modeling approaches in academia and industry followed by an interpretation of the FDA bill, namely cell culture, organoid, organ-on-a-chip, 3D bio-printing model and computer-based model. The paper next introduces the crossed applications of various disease models and discusses the advantages and disadvantages of each system, thereby providing insights into future trends in the use of animal disease models in China.

Key words: Animal disease models, In vitro disease models, Organoid, Organ-on-a-chip, 3D bio-printing, FDA Modernization Act 2.0

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