Xenotransplantation Action Plan
Available Documents

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Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) - 4/9/2008

Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans - 4/3/2003

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 - (PDF, 227 KB)

Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product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

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

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, 133 KB)

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

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Updated: April 14, 2008