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  • Draft Guidance on Cell, Gene Therapy Products Establishes General Framework

    The US Food and Drug Administration (FDA) has release a new draft document aimed at providing guidance on the preclinical assessment of cellular, tissue and gene (CTG) therapy products. CTGs are essentially used to make therapeutic changes to a person's cells, tissue or genes by injecting a patient with altered DNA, cells or implanted with organs. The products include cellular therapies, gene therapies, therapeutic vaccines, xenotransplantation and other drug products, i...