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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 CanadaCytotherapyVol. 21Issue 7
- PreviewA 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.
- Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizonCytotherapyVol. 21Issue 7
- PreviewCellular & Gene Therapies (CGTs) are complex products, which have been key foci of the International Society for Cell & Gene Therapy (ISCT). For this ISCT North American Legal & Regulatory Affairs Committee review publication, CGTs include but are not limited to somatic cell-based therapies, pluripotent cell-derived cell-based therapies, gene- or non-gene-modified or gene edited versions of these cell-based therapies, in vivo gene therapies, organ/tissue engineered products, and relevant combination products.