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As tendon organoids move closer to clinical application, Author contributions
regulatory and economic considerations become
increasingly critical. Regulatory pathways, however, remain Conceptualization: Xiao Chen, Zi Yin, Yiwen Xue, Yixi Wu
nebulous. Regulatory agencies like the Food and Drug Data curation: Yiwen Xue, Yixi Wu
Administration (FDA) currently lack specific guidelines Supervision: Hong Zhang, Xiao Chen, Huanhuan Liu,
Zi Yin
for organoid-based products. In December 2022, the Project administration: Yiwen Xue, Hong Zhang, Xiao
United States enacted the FDA Modernization Act 2.0, Chen, Huanhuan Liu, Zi Yin
amending the Food, Drug, and Cosmetic Act to remove Visualization: Yiwen Xue, Yixi Wu
the compulsory requirement for animal experimentation Writing–original draft: Yiwen Xue, Yixi Wu
in drug development. This legislative change permits the Writing–review & editing: All authors
use of alternative methods, including organoid models, for
evaluating drug safety and efficacy before human clinical Ethics approval and consent to participate
trials. More specific official regulations for replacing
animals with organoids in experiments are forthcoming, Not applicable.
necessitating collaborations between researchers and
policymakers. Adaptive licensing frameworks, similar Consent for publication
194
to those proposed for gene therapies, may accelerate Not applicable.
translation while ensuring safety. Concurrently, cost-
effectiveness analyses must address whether organoid- Availability of data
based therapies offer advantages over existing options, such Not applicable.
as autografts, particularly in resource-limited settings.
References
7. Conclusion
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Acknowledgments 4. Abat F, Alfredson H, Cucchiarini M, et al. Current trends
in tendinopathy: Consensus of the ESSKA basic science
We thank Dr. Tian Qin for generously providing committee. Part I: Biology, biomechanics, anatomy and an
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National Natural Science Foundation of China grants 6. Teunis T, Lubberts B, Reilly BT, Ring D. A systematic
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Volume 1 Issue 3 (2025) 18 doi: 10.36922/OR025170016