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Xenotransplant News

Xenotransplant News Transplantation Society Miami Congress, 25–30 August 2002 This will be held at the Westin Diplomat Resort and Conference Center. Details can be obtained from www.transplantation‐soc.org or www.transplantation2002.com , or from Felicissimo & Associates, Inc. (tel.: 514‐874‐1998; fax: 514‐874‐1580; e‐mail: info@transplantation‐soc.org ). US Food and Drug Administration draft guidance for industry The US Food and Drug Administration (FDA) has posted a revised (yet still draft) guidance document on blood donor deferral for xenotransplantation product recipients and their close contacts ( Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and their Intimate Contacts ). The revised document now includes a definition of intimate contact and includes a revised set of blood donor questions. This original version of the document was the subject of discussion at two separate advisory committee meetings in 2000, and significant public commentary was received. The FDA has tried to address the discussions and comments, but felt that it was prudent to publish the guidance again in draft form. The document has been posted on CBER's website. The information can be reached from the Guidelines page at http://www.fda.gov/cber/guidelines.htm , or from http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Xenotransplantation Wiley

Xenotransplant News

Xenotransplantation , Volume 9 (4) – Jul 1, 2002
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Publisher
Wiley
Copyright
Copyright © 2002 Wiley Subscription Services, Inc., A Wiley Company
ISSN
0908-665X
eISSN
1399-3089
DOI
10.1034/j.1399-3089.2002.02021.x
Publisher site
See Article on Publisher Site

Abstract

Transplantation Society Miami Congress, 25–30 August 2002 This will be held at the Westin Diplomat Resort and Conference Center. Details can be obtained from www.transplantation‐soc.org or www.transplantation2002.com , or from Felicissimo & Associates, Inc. (tel.: 514‐874‐1998; fax: 514‐874‐1580; e‐mail: info@transplantation‐soc.org ). US Food and Drug Administration draft guidance for industry The US Food and Drug Administration (FDA) has posted a revised (yet still draft) guidance document on blood donor deferral for xenotransplantation product recipients and their close contacts ( Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and their Intimate Contacts ). The revised document now includes a definition of intimate contact and includes a revised set of blood donor questions. This original version of the document was the subject of discussion at two separate advisory committee meetings in 2000, and significant public commentary was received. The FDA has tried to address the discussions and comments, but felt that it was prudent to publish the guidance again in draft form. The document has been posted on CBER's website. The information can be reached from the Guidelines page at http://www.fda.gov/cber/guidelines.htm , or from

Journal

Xenotransplantation – Wiley

Published: Jul 1, 2002

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