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, 2023 09.
Article
em En
| MEDLINE
| ID: mdl-37217005
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.
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Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Cirurgiões
/
Motivação
Limite:
Animals
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Humans
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article