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

Publication ,  Journal Article
Adams, A; Cendales, LC; Cooper, DKC; Cozzi, E; Gill, J; Judd, E; Katz, E; Kirk, AD; Fishman, JA; Reese, PP; Wall, A; Markmann, JF
Published in: Am J Transplant
September 2023

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.

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Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

September 2023

Volume

23

Issue

9

Start / End Page

1290 / 1299

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Transplantation, Heterologous
  • Swine
  • Surgery
  • Surgeons
  • Motivation
  • Humans
  • Animals
  • 3204 Immunology
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Adams, A., Cendales, L. C., Cooper, D. K. C., Cozzi, E., Gill, J., Judd, E., … Markmann, J. F. (2023). American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products. Am J Transplant, 23(9), 1290–1299. https://doi.org/10.1016/j.ajt.2023.05.010
Adams, Andrew, Linda C. Cendales, David K. C. Cooper, Emanuele Cozzi, John Gill, Eric Judd, Eliezer Katz, et al. “American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products.Am J Transplant 23, no. 9 (September 2023): 1290–99. https://doi.org/10.1016/j.ajt.2023.05.010.
Adams A, Cendales LC, Cooper DKC, Cozzi E, Gill J, Judd E, et al. American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products. Am J Transplant. 2023 Sep;23(9):1290–9.
Adams, Andrew, et al. “American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products.Am J Transplant, vol. 23, no. 9, Sept. 2023, pp. 1290–99. Pubmed, doi:10.1016/j.ajt.2023.05.010.
Adams A, Cendales LC, Cooper DKC, Cozzi E, Gill J, Judd E, Katz E, Kirk AD, Fishman JA, Reese PP, Wall A, Markmann JF. American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products. Am J Transplant. 2023 Sep;23(9):1290–1299.
Journal cover image

Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

September 2023

Volume

23

Issue

9

Start / End Page

1290 / 1299

Location

United States

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Transplantation, Heterologous
  • Swine
  • Surgery
  • Surgeons
  • Motivation
  • Humans
  • Animals
  • 3204 Immunology