Xenotransplantation Subcommittee January 13, 2000

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Table of Contents

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 Recommendations: Animal Procurement Sources and Facility

PHS Recommendations: Animal Procurement Sources and Facility

PHS Recommendations: Animal Procurement Sources and Facility

PHS and FDA Recommendations: Screening of the Xenotransplantation Product

PHS and FDA Recommendations: Screening of the Xenotransplantation Product

PHS and FDA Recommendations: Screening of the Xenotransplantation Product

PHS and FDA Recommendations: Recipient Education and Surveillance

PHS and FDA Recommendations: Recipient Education and Surveillance

PHS and FDA Recommendations: Recipient Education and Surveillance

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: 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: Species of Source Animal

FDA Questions/Proposals re Other Products: Species of Source Animal

FDA Questions/Proposals re Other Products: Species of Source Animal

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: Cell Line vs. Fresh Tissue

FDA Questions/Proposals re Other Products: Approaches which quantitatively reduce risk

FDA Questions/Proposals re Other Products: Approaches which quantitatively reduce risk

FDA Questions/Proposals re Other Products: Immunosuppression

Author: FDA

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