title: Xenotransplantation: regulatory challenges.
abstract: During 1999-2000, the US government published three xenotransplantation policy/guidance documents, one by the Public Health Service and two by the Food and Drug Administration (FDA). The FDA also held two public meetings of the xenotransplantation subcommittee of the Biological Response Modifiers Advisory Committee to discuss particular issues in xenotransplantation.
authors.affiliation: Division of Cellular and Gene Therapies (HFM-518), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, 20852, Rockville, MD, USA. bloom@cber.fda.gov
authors.forename: E T
authors.initials: ET
authors.lastname: Bloom
mesh_terms: D000818:Animals; D004493:Education; D005060:Europe; D006801:Humans; D007390:International Agencies; D020407:Internet; D011640:Public Policy; D014183:Transplantation, Heterologous / Q000592:standards* / Q000662:veterinary; D014481:United States; D014486:United States Food and Drug Administration; D014492:United States Public Health Service; D014944:World Health Organization