American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products

Andrew Adams, Linda C. Cendales, David K.C. Cooper, Emanuele Cozzi, John Gill, Eric Judd, Eliezer Katz, Allan D. Kirk, Jay A. Fishman, Peter P. Reese, Anji Wall, James F. Markmann*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

In June 2022, the US Food and Drug Administration Center for Biologics Evaluation and Research held the 73rd meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee for public discussion of regulatory expectations for xenotransplantation products. The members of a joint American Society of Transplant Surgeons/American Society of Transplantation committee on xenotransplantation compiled a meeting summary focusing on 7 topics believed to be key by the committee: (1) preclinical evidence supporting progression to a clinical trial, (2) porcine kidney function, (3) ethical aspects, (4) design of initial clinical trials, (5) infectious disease issues, (6) industry perspectives, and (7) regulatory oversight.

Original languageEnglish
Pages (from-to)1290-1299
Number of pages10
JournalAmerican Journal of Transplantation
Volume23
Issue number9
DOIs
StatePublished - Sep 2023
Externally publishedYes

Keywords

  • kidney transplant
  • regulatory
  • xenotransplantation

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