Guidance for human somatic cell therapy and gene therapy. March 1998. Center for Biologics Evaluation and Research, Food and Drug Administration.
D032761:Animal Experimentation; D017690:Cell Transplantation / Q000331:legislation & jurisprudence / Q000592:standards*; D005069:Evaluation Studies as Topic; D015316:Genetic Therapy / Q000331:legislation & jurisprudence / Q000592:standards*; D005822:Genetic Vectors / Q000592:standards; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D010957:Plasmids / Q000592:standards; D014015:Tissue Banks / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*