News & Press Releases: Breaking News

ISCT NA LRA Releases Two Publications on the State of FDA and HC Regulation for CGT Products

Friday, June 14, 2019  
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ISCT North America Legal & Regulatory Affairs (NA LRA) Committee Releases Two Review Publications on the Current State of US FDA and Health Canada Regulation for Cell & Gene Therapy Products

A major hurdle for worldwide development of Cellular & Gene Therapy Products (CGT) is the differing regulatory structures within various geographic jurisdictions. These differences impact patient access to innovative, potentially revolutionary and curative medical therapies. The International Society for Cell & Gene Therapy (ISCT) intends to contribute to the improving development and regulatory approval of CGTs in all areas of the globe. The first and second reviews in this potential global series is authored by the ISCT North America Legal & Regulatory Affairs (NA LRA) Committee and focuses specifically on the U.S and Canada.  It is currently available in CytotherapyTM online and will be printed in the July issue.

These reviews cover information such as current legislation, regulation, guidance documents, regulatory submissions, regulatory meetings, expedited programs, regulatory science, and other relevant information with regards to CGTs from the U.S. and Canadian perspectives, respectively.  Thge aim is to provide both a high-level educational tool and roadmap for scientists new to the field as well as a comprehensive reference for established experts, in order to help support product and clinical development in the respective geography. The ISCT NA LRA intends that these publications will help readers position their CGTs for global product approval and will provide updates as appropriate.   Similar regulatory reviews may be generated for other jurisdictions given ISCT’s global mandate, as part of an ongoing global series of reviews. 


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