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Forward for two review articles authored by ISCT's North American Legal & Regulatory Affairs Committee on the regulatory framework for cellular & gene therapy product approval in the U.S. and Canada

      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)'s intent is 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, authored by ISCT's North American Legal & Regulatory Affairs Committee, focus on North America, specifically U.S. and Canada, in this 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. It was our intent to provide both a high-level roadmap for scientists new to the field, and a comprehensive reference for the veterans amongst us, in order to help support product and clinical development in the respective geography. We hope similar regulatory reviews will also be generated for other jurisdictions given ISCT's global mandate, as part of an ongoing global series of reviews. We also intend to provide updates, as appropriate. ISCT intends that these publications will help readers position their CGTs for global product approval.
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