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Impact of genetically modified organism requirements on gene therapy development in the EU, Japan, and the US

Advanced therapies are emerging as an important class of medicinal products; among these, gene therapies are advancing at an exceptional rate. However, one of the major challenges for gene therapies relates to the additional regulatory requirements for genetically modified organisms. In this paper,...

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Detalles Bibliográficos
Autores principales: Tajima, Gentaro, Huh, Seoan, Schmidt, Natalie Anne, Macdonald, Judith C., Fleischmann, Tobias, Wonnacott, Keith Merrell
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Gene & Cell Therapy 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9207611/
https://www.ncbi.nlm.nih.gov/pubmed/35782596
http://dx.doi.org/10.1016/j.omtm.2022.05.012

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