Xenotransplantation Action Plan
FDA Approach to the Regulation of Xenotransplantation
Available Documents
Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans - 4/3/2003 -
(PDF),
(Text)
Human Cells or Tissues Intended for Transplant Into a Human Recipient That Have Ex-vivo Contact With Live Nonhuman Animal Cells, Tissues, or Organs Letter - 3/8/2002 -
(Text),
(PDF)
Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts - 2/1/2002 -
(PDF),
(Text)
- Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts - (64 FR 73562 - 73563, Dec. 30, 1999) - 12/23/1999 -
(PDF),
(Text)
Letter on Stem Cells to Senator Kennedy - 9/5/2001
Letter on Stem Cells to Senator Gregg - 9/5/2001
PHS Guideline on Infectious Disease Issues in Xenotransplantation - 1/19/2001 -
(PDF),
(Text)
- FEDERAL REGISTER Notice of Availability - 1/29/2001 -
(PDF),
(Text)
FEDERAL REGISTER Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain Data and Information Related to Human Gene Therapy or Xenotransplantation; Proposed Rule - 1/18/2001 -
(PDF),
(Text)
Notice of Availability, "Guidance For Industry: Public Health Issues Posed by the Use of Non-Human Primate Xenografts in Humans" (64 FR 16743-16744, April 6, 1999).
Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals - 7/19/1993
(PDF)
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