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Regulatory considerations for gene therapy products in the US, EU, and Japan

Abstract:

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 fall in the United States, the European Union, and Japan, and a comprehensive overview of the regulatory guidance applicable to the developer of GTP. Understanding the regulatory requirements for s...

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Publication status:
Published
Peer review status:
Peer reviewed
Version:
Publisher's version

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Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
Paediatrics
More by this author
Institution:
University of Oxford
Division:
Medical Sciences Division
Department:
NDORMS
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SENS Research Foundation More from this funder
Centre for the Advancement of Sustainable Medical Innovation More from this funder
Medical Research Council More from this funder
National Institute for Health Research More from this funder
Saïd Foundation More from this funder
Publisher:
Yale School of Medicine Publisher's website
Journal:
Yale Journal of Biology and Medicine Journal website
Volume:
90
Issue:
4
Pages:
683-693
Publication date:
2017-12-05
Acceptance date:
2017-11-19
EISSN:
1551-4056
ISSN:
0044-0086
Pubs id:
pubs:747016
URN:
uri:ceada12a-929c-4905-a5fe-690a20088d01
UUID:
uuid:ceada12a-929c-4905-a5fe-690a20088d01
Local pid:
pubs:747016

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