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GUIDANCE DOCUMENT

PHS Guideline on Infectious Disease Issues in Xenotransplantation PHS Guideline January 2001

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

On behalf of the U.S. Public Health Service (PHS), the Food and Drug Administration (FDA) is announcing the availability of a guideline entitled ‘‘PHS Guideline on Infectious Disease Issues in Xenotransplantation’’ dated January 19, 2001. This guideline was developed by the PHS to identify general principles for the prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to public health. The guideline is intended to provide general guidance to local review bodies evaluating proposed xenotransplantation protocols and to sponsors in developing xenotransplantation protocols, in preparing submissions to FDA and the Secretary’s Advisory Committee on Xenotransplantation, and in conducting xenotransplantation clinical trials.

 


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Dockets Management
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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
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Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010