The impact of regulatory policy on the development of somatic cell therapies in the United States.
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.
Center For Cell and Gene Therapy, Baylor College of Medicine, Feigin Center, Houston, TX 77030, USA. apgee@txccc.org
Adrian P
AP
Gee
D000068:Accreditation; D000818:Animals; D017690:Cell Transplantation / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards; D005161:Facility Regulation and Control / Q000331:legislation & jurisprudence; D015316:Genetic Therapy / Q000191:economics / Q000331:legislation & jurisprudence* / Q000592:standards; D017048:Health Care Costs; D006291:Health Policy / Q000331:legislation & jurisprudence; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration