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.
Gee
Adrian P
AP
Center For Cell and Gene Therapy, Baylor College of Medicine, Feigin Center, Houston, TX 77030, USA. apgee@txccc.org
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