Vaccines, Blood & Biologics

Public Symposium: IXA-FDA Symposium on Regulatory Expectations for Xenotransplantation Products

SUMMARY

The International Xenotransplantation Association (IXA) and the Food and Drug Administration (FDA) and are co-sponsoring a symposium on xenotransplantation titled “IXA-FDA Symposium on Regulatory Expectations for Xenotransplantation Products”.

Background:

Since the early 1990s xenotransplantation has been proposed as an option to circumvent the shortage of human organs available for transplantation. Recent advances in the pig to primate preclinical models for human xenotransplantation and the 2016 update of the CBER 2003 Guidance Document “Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans” has  prompted further interest in public discussions on scientific advances and regulatory expectations for xenotransplantation clinical trials.
The goals of the symposium are as follows:

  1. Update the scientific and lay community on the latest advances in xenotransplantation
  2. Assess the public health risks associated with xenotransplantation, and advances in genetic engineering of animals used for xenotransplantation

DATE:

September 20, 2017
8:00 AM – 12:00 PM

LOCATION:

University of Maryland SMC Center
621 W. Lombard Street
Baltimore, MD 21201

REGISTRATION:

To register for this symposium, please visit the following Web site: www.IXA2017.org
There is no charge for attendance. For more information, please contact Judith Arcidiacono at Judith.Arcidiacono@FDA.HHS.GOV, 240-402-8250

Page Last Updated: 08/04/2017
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