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

Abstract

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 development of biologic products and to stimulate discussion in areas in which policy is still being formulated.