Xenotransplantation Subcommittee January 13, 2000
Brief Background
Brief Background- continued
Definitions
Rationale for Definition of Xenotransplantation
Implications of Definitions
Epicel: A Xenotransplantation Product
Brief Review of Recommendations
PHS Recommendations: Animal Procurement Sources and Facility
PHS and FDA Recommendations: Screening of the Xenotransplantation Product
PHS and FDA Recommendations: Recipient Education and Surveillance
FDA Recommendations: Blood Donor Deferral
CBER/FDA Questions/Proposals re Epicel
CBER/FDA Questions/Proposals re Epicel: Animal procurement sources and facilities
CBER/FDA Questions/Proposals re Epicel: Screening of the Xenotransplantation Product
CBER/FDA Questions/Proposals re Epicel: Recipient Education and Surveillance
CBER/FDA Questions/Proposals re Epicel: Database
CBER/FDA Questions/Proposals re Epicel: Blood donor deferral
FDA Questions/Proposals re Other Products
FDA Questions/Proposals re Other Products: Species of Source Animal
FDA Questions/Proposals re Other Products: Cell Line vs. Fresh Tissue
FDA Questions/Proposals re Other Products: Approaches which quantitatively reduce risk
FDA Questions/Proposals re Other Products: Immunosuppression
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