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GUIDANCE DOCUMENT

Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans Guidance For Industry April 1999

Final

Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans

Docket Number:
96M-0311
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This document is intended to provide guidance on nonhuman primate xenotransplantation.Xenotransplantation is defined for the purpose of this document as the use of live cells,tissues, or organs from a nonhuman animal source transplanted or implanted into a human, or used for ex vivo contact with human body fluids, cells, tissues, or organs that are subsequently given to a human recipient. For the purpose of this document, xenografts include live cells, tissues or organs from a nonhuman animal source used for xenotransplantation. This document provides guidance to industry concerning: (1) the potential public health risks posed by nonhuman primate xenografts; (2) the need for further scientific research and evaluation of these risks, particularly infectious agents; and (3) the need for public discussion concerning these issues.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 96M-0311.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010