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Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union

Legislation for expedited‐approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting fro...

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Detalles Bibliográficos
Autores principales: Jokura, Yoji, Yano, Kazuo, Yamato, Masayuki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5836905/
https://www.ncbi.nlm.nih.gov/pubmed/28211195
http://dx.doi.org/10.1002/term.2428