American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products
Copyright © 2023 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
|---|---|
| Enthalten in: |
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons - 23(2023), 9 vom: 01. Sept., Seite 1290-1299 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Adams, Andrew [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Journal Article |
|---|
| Anmerkungen: |
Date Completed 23.10.2023 Date Revised 07.11.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.ajt.2023.05.010 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM357194713 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM357194713 | ||
| 003 | DE-627 | ||
| 005 | 20231226072049.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.ajt.2023.05.010 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1190.xml |
| 035 | |a (DE-627)NLM357194713 | ||
| 035 | |a (NLM)37217005 | ||
| 035 | |a (PII)S1600-6135(23)00471-9 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Adams, Andrew |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 23.10.2023 | ||
| 500 | |a Date Revised 07.11.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a kidney transplant | |
| 650 | 4 | |a regulatory | |
| 650 | 4 | |a xenotransplantation | |
| 700 | 1 | |a Cendales, Linda C |e verfasserin |4 aut | |
| 700 | 1 | |a Cooper, David K C |e verfasserin |4 aut | |
| 700 | 1 | |a Cozzi, Emanuele |e verfasserin |4 aut | |
| 700 | 1 | |a Gill, John |e verfasserin |4 aut | |
| 700 | 1 | |a Judd, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Katz, Eliezer |e verfasserin |4 aut | |
| 700 | 1 | |a Kirk, Allan D |e verfasserin |4 aut | |
| 700 | 1 | |a Fishman, Jay A |e verfasserin |4 aut | |
| 700 | 1 | |a Reese, Peter P |e verfasserin |4 aut | |
| 700 | 1 | |a Wall, Anji |e verfasserin |4 aut | |
| 700 | 1 | |a Markmann, James F |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons |d 2001 |g 23(2023), 9 vom: 01. Sept., Seite 1290-1299 |w (DE-627)NLM119667924 |x 1600-6143 |7 nnns |
| 773 | 1 | 8 | |g volume:23 |g year:2023 |g number:9 |g day:01 |g month:09 |g pages:1290-1299 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.ajt.2023.05.010 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 23 |j 2023 |e 9 |b 01 |c 09 |h 1290-1299 | ||