Regulation of Somatic-Cell Therapy and Gene Therapy by the Food and Drug Administration

Abstract excerpt

Scientific advances in the past decade have made the clinical testing of somatic-cell therapy and gene therapy a reality. Early trials in humans suggest that important new diagnostic and therapeutic tools are on the horizon. The objectives of this article are to examine the regulation of somatic-cell and gene therapy by the Food and Drug Administration (FDA) in the context of the agency's traditional role in the...

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