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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Vydáno v:Yale J Biol Med
Hlavní autoři: Halioua-Haubold, Celine-Lea, Peyer, James G., Smith, James A., Arshad, Zeeshaan, Scholz, Matthew, Brindley, David A., MacLaren, Robert E.
Médium: Artigo
Jazyk:Inglês
Vydáno: YJBM 2017
Témata:
Analyses
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC5733859/
https://ncbi.nlm.nih.gov/pubmed/29259533
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