The impact of regulatory policy on the development of somatic cell therapies in the United States

Transpl Immunol. 2002 May;9(2-4):295-300. doi: 10.1016/s0966-3274(02)00012-6.


Cellular therapies offer new promise for the treatment of a variety of diseases. In order to protect patients and donors, the Food and Drug Administration in the USA has been developing specific regulations. These have undergone several iterations, however, a broad-based strategy has recently emerged. These proposals are reviewed and their impact on academic institutions is assessed.

MeSH terms

  • Accreditation
  • Animals
  • Cell Transplantation / economics
  • Cell Transplantation / legislation & jurisprudence*
  • Cell Transplantation / standards
  • Facility Regulation and Control / legislation & jurisprudence
  • Genetic Therapy / economics
  • Genetic Therapy / legislation & jurisprudence*
  • Genetic Therapy / standards
  • Health Care Costs
  • Health Policy / legislation & jurisprudence
  • Humans
  • United States
  • United States Food and Drug Administration