Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

Miscellaneous

Miscellaneous JOINT FDA‐IXA SYMPOSIUM, SEPTEMBER 20, 2017SummaryAt the American Transplant Congress, June 2016 in Boston—USA, an informal closed meeting between members of the IXA Council and representatives from the US Food and Drug Administration (FDA) was organized around discussing a core goal of IXA: “to facilitate the transition of xenotransplantation to the clinic, as safely as possible, and as soon as preclinical evidence supports doing so.” In light of new information regarding significant improvements in both clinical safety profile and preclinical efficacy outcomes in several xenotransplantation modalities, as a result of that informal conversation, FDA and IXA agreed that a renewed public consultative process is timely.Consequently, FDA and IXA planned a joint symposium regarding current state‐of‐the‐art and related regulatory perspectives on September 20, 2017, preceding the IXA 2017 Congress in Baltimore, MD, USA. The meeting was organized by Muhammad M. Mohiuddin, representing the IXA Council, and colleagues from the FDA. Advanced notice of this meeting was posted on the IXA (www.tts.org/ixa/home) and FDA (www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm570253.htm) websites. In addition, all meeting materials including video recordings of the presentation will be posted on the IXA website. Summaries of the presentations follow here, ordered according to the sequence of the presentations.The symposium included three http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Xenotransplantation Wiley

Miscellaneous

Download PDF
17 pages

Loading next page...
 
/lp/wiley/miscellaneous-OD3ZK07n04

References (109)

Publisher
Wiley
Copyright
© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
ISSN
0908-665X
eISSN
1399-3089
DOI
10.1111/xen.12365
pmid
29193342
Publisher site
See Article on Publisher Site

Abstract

JOINT FDA‐IXA SYMPOSIUM, SEPTEMBER 20, 2017SummaryAt the American Transplant Congress, June 2016 in Boston—USA, an informal closed meeting between members of the IXA Council and representatives from the US Food and Drug Administration (FDA) was organized around discussing a core goal of IXA: “to facilitate the transition of xenotransplantation to the clinic, as safely as possible, and as soon as preclinical evidence supports doing so.” In light of new information regarding significant improvements in both clinical safety profile and preclinical efficacy outcomes in several xenotransplantation modalities, as a result of that informal conversation, FDA and IXA agreed that a renewed public consultative process is timely.Consequently, FDA and IXA planned a joint symposium regarding current state‐of‐the‐art and related regulatory perspectives on September 20, 2017, preceding the IXA 2017 Congress in Baltimore, MD, USA. The meeting was organized by Muhammad M. Mohiuddin, representing the IXA Council, and colleagues from the FDA. Advanced notice of this meeting was posted on the IXA (www.tts.org/ixa/home) and FDA (www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm570253.htm) websites. In addition, all meeting materials including video recordings of the presentation will be posted on the IXA website. Summaries of the presentations follow here, ordered according to the sequence of the presentations.The symposium included three

Journal

Xenotransplantation – Wiley

Published: Jan 1, 2017

There are no references for this article.