We understand the FDA guidelines and their applicabilty to provide a comprehensive approach for the regulation of xenotransplantation that addresses the potential public health safety issues associated with xenotransplantation and to provide guidance to sponsors, manufacturers and investigators regarding xenotransplantation product safety and clinical trial design and monitoring.
Facility Design and Validation
We have extensive experience in the design, qualification and validation of animal facilities for xenotransplantation applications and can develop all FDA required documentation, monitoring programs and commissioning.
Product Development, Manufacturing and Testing
Contact us to learn how we can help you set up a development program, implement all manufacturing procedures, testing methods, specifications and CMC controls for your xeno therapeutic product.
Here is a partial list of available documents from FDA's Xenotransplantation Action Plan:
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Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product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
Back to Action Plan Main Page