Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan

Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European Union (EU), and Japan. In this study, the defini...

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Detalhes bibliográficos
Publicado no:Regen Ther
Main Authors: Yano, Kazuo, Watanabe, Natsumi, Tsuyuki, Kenichiro, Ikawa, Taisuke, Kasanuki, Hiroshi, Yamato, Masayuki
Formato: Artigo
Idioma:Inglês
Publicado em: Japanese Society for Regenerative Medicine 2014
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Original Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6581762/
https://ncbi.nlm.nih.gov/pubmed/31589662
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.reth.2014.10.001
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