Cell transplantation and Federal regulation.
Federal regulation of tissues and organs has proceeded slowly, with main emphasis on safety of the procured material. More recently with the development of somatic cell therapies, the Food and Drug Administration has issued some guidance documents that establish that some classes of cells that are manufactured will be subject to not only safety but efficacy requirements. Cell transplantation presents several aspects that are similar to somatic cell therapies, and the purpose of this presentation is to explore those relationships.
Noguchi
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Division of Cellular and Gene Therapies, Food and Drug Administration, Rockville, MD 20852-1448, USA.
D017690:Cell Transplantation / Q000009:adverse effects / Q000331:legislation & jurisprudence*; D006801:Humans; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration