Lexology May 21, 2024
FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in the last few years and the unprecedented approval, on the same day in 2023, of a novel gene editing product and another gene therapy product for sickle cell disease. Although FDA’s approval rate remains slower than the one to two applications that FDA receives each week for new gene therapy products, the agency continues to demonstrate commitment to the accelerated development of these products. The agency recently increased its repertoire of tools for accelerating the development of CTGT products by providing additional opportunities for early interactions with sponsors, as we...
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