New FDA xenotransplantation documents: a proposed rule and a draft guidance.
Bloom
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Food and Drug Administration, Center for Biologics Evaluation and Research, Division of Cellular and Gene Therapies, FDA/CBER/DCGT/LCI (HFM-518), Bldg. 29B/Room 2NN04, 8800 Rockville Pike, Bethesda, MD 20892, USA. bloom@cber.fda.gov
D000818:Animals; D017408:Guidelines as Topic; D006801:Humans; D011785:Quality Assurance, Health Care; D014183:Transplantation, Heterologous / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration