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GUIDANCE DOCUMENT

Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans Guidance for Industry December 2016

Final
Docket Number:
00D-1662
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) is issuing this guidance to provide sponsors and applicants of xenotransplantation products with updates concerning the production, testing, and evaluation of products, during protocol development and during the preparation of submissions to FDA, e.g., Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs). This guidance also includes updated references and Agency practices intended to prevent the introduction and spread of infectious agents of animal origin into the human population. This guidance amends the guidance of the same title dated April 2003 (April 2003 guidance).

 


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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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 00D-1662.

Questions?

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