Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan


Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs...

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Detalles Bibliográficos
Autores principales: Halioua-Haubold, Celine-Lea, Peyer, James G., Smith, James A., Arshad, Zeeshaan, Scholz, Matthew, Brindley, David A., MacLaren, Robert E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: YJBM 2017
Materias:
Analyses
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5733859/
https://www.ncbi.nlm.nih.gov/pubmed/29259533

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5733859/
https://www.ncbi.nlm.nih.gov/pubmed/29259533

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