National policies for xenotransplantation in the USA.
An overview of xenotransplantation regulatory policies in the USA was presented at the Satellite Symposium, ''Xenotransplantation--Current Standards for Clinical Trials,'' held in conjunction with the World Transplant Congress, Boston, MA, USA 2006. This article summarizes that overview.
Gene Transfer and Immunogenicity Branch, Division of Cellular and Gene Therapies, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA. eda.bloom@fda.hhs.gov
Eda T
ET
Bloom
D000818:Animals; D002986:Clinical Trials as Topic / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D011640:Public Policy; D014183:Transplantation, Heterologous / Q000331:legislation & jurisprudence* / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards