XENOTRANSPLANTATION SUBCOMMITTEE

of the

BIOLOGICAL RESPONSE MODIFIERS ADVISORY COMMITTEE

January 13, 2000

Briefing Information

*Paradis, Khazal, et al; "Search for Cross-Species Transmission of Porcine Endogenous Retrovirus in Patients Treated with Living Pig Tissue," Science, 285:1236-1241, 20Aug 1999.

Novartis Presentation Slides

 Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from xenotranssplantation Product Recipients and Their Contacts, Draft Guidance

"Draft Public Health Service (PHS) Guideline on Infectious Disease Issues in Xenotransplantation (August 1996)," September 23, 1996 (61F49919). [ htm] [ pdf ]

GENZYME TISSUE REPAIR Submissions

Confidentiality Statement

Epicelš (cultured epidermal autografts) background information

Epicel Introduction

The Use of Well Characterized, Non-Human, Cell Lines in the Production of Medical Products, W. Alan Moore, Primedica Corporation

Characterization of Swiss Mouse Embryo 3T3 Cell Bank used in Epicel ‘ Autograft Cultivation, Bruce M. Wentworth, PhD, Genzyme Tissue Repair

FOOD AND DRUG ADMINISTATION Submission

Background Summary: Sesssion on FDA Xenotransplantation Policy Development

Xenotransplantation Advisory Committee Meeting (January 13, 2000)

 

 

 

*This document contains copyrighted material. The document may be viewed at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852