Ontology highlight
ABSTRACT:
SUBMITTER: Halioua-Haubold CL
PROVIDER: S-EPMC5733859 | biostudies-literature | 2017 Dec
REPOSITORIES: biostudies-literature
Halioua-Haubold Celine-Lea CL Peyer James G JG Smith James A JA Arshad Zeeshaan Z Scholz Matthew M Brindley David A DA MacLaren Robert E RE
The Yale journal of biology and medicine 20171219 4
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 seek ...[more]