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In this section: Biologics Guidances

Xenotransplantation Guidances

Pig Kidney Transplant concept as a genetically modified animal organ transferred to humans as Xenotransplantation technology or Xenogeneic transplantation as bioengineered DNA.

Should you find a link that does not work within any Guidance document, Rule or other document posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.

Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans; Guidance for Industry
CBER 12/13/2016
PHS Guideline on Infectious Disease Issues in Xenotransplantation
1/19/2001 (Updated June 23, 2022)

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