@article{a215a905b6d045ed8dbae959e6a57d9e,
title = "American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products",
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.",
keywords = "kidney transplant, regulatory, xenotransplantation",
author = "Andrew Adams and Cendales, {Linda C.} and Cooper, {David K.C.} and Emanuele Cozzi and John Gill and Eric Judd and Eliezer Katz and Kirk, {Allan D.} and Fishman, {Jay A.} and Reese, {Peter P.} and Anji Wall and Markmann, {James F.}",
note = "Funding Information: The authors thank their colleagues on the ASTS-AST Xenotransplantation Committee for their valuable thoughts and contributions to this work: Cesar Arias, Nancy Bridges, Will Chapman, Sandy Feng, Richard Formica, Ahmed O. Gaber, Wayne Hawthorne, Deepali Kumar, Jayme Locke, Marc Lorber, Muhammad Mohiuddin, Robert Montgomery, Jonah Odim, David H. Sachs, Megan Sykes, Alfred J. Tector, and Kaz Yamada. Publisher Copyright: {\textcopyright} 2023 American Society of Transplantation & American Society of Transplant Surgeons",
year = "2023",
month = sep,
doi = "10.1016/j.ajt.2023.05.010",
language = "English",
volume = "23",
pages = "1290--1299",
journal = "American Journal of Transplantation",
issn = "1600-6135",
number = "9",
}