Regulatory Issues

In the USA, gene therapy protocols attract an additional degree of regulatory review. Not only must an IND be approved by the US FDA, but also the protocol must be approved by the Recombinant DNA Advisory Committee of the National Institutes of Health (the 'RAC'). To date, many dozens of such protocols have been approved, with the largest group for therapies that are designed to increase production of a specific cytokine in a specific tissue location. In Europe there is no RAC-equivalent, and regulatory requirements are handled within the national regulatory authorities, reviewing research protocols for investigational agents, and the EMEA and CPMP, reviewing the final product licence applications (see Chapter 28).

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