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.
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Transmission of Zoonoses by Blood and Blood Products from xenotranssplantation Product Recipients and Their Contacts, Draft Guidance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
Epicelä (cultured epidermal autografts) background information
FOOD AND DRUG ADMINISTATION Submission
*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