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

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

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 Socie...

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Veröffentlicht in:American journal of transplantation 2023-09, Vol.23 (9), p.1290-1299
Hauptverfasser: Adams, Andrew, Cendales, Linda C., Cooper, David K.C., Cozzi, Emanuele, Gill, John, Judd, Eric, Katz, Eliezer, Kirk, Allan D., Fishman, Jay A., Reese, Peter P., Wall, Anji, Markmann, James F.
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kidney transplant
regulatory
xenotransplantation
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container_end_page 1299
container_issue 9
container_start_page 1290
container_title American journal of transplantation
container_volume 23
creator Adams, Andrew
Cendales, Linda C.
Cooper, David K.C.
Cozzi, Emanuele
Gill, John
Judd, Eric
Katz, Eliezer
Kirk, Allan D.
Fishman, Jay A.
Reese, Peter P.
Wall, Anji
Markmann, James F.
description 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.
doi_str_mv 10.1016/j.ajt.2023.05.010
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source Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection
subjects kidney transplant
regulatory
xenotransplantation
title American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products
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