Foundation for the Accreditation of Hematopoietic Cell Therapy (FAHCT) response to FDA (Docket no. 97N-0068). FAHCT Board of Directors.
We believe the proposed model is appropriate to our current state of knowledge and recognize that FDA regulations will evolved as the field evolves. We thank you for the opportunity to work with FDA as its regulatory strategy is developed in the near future.
Shpall
E J
EJ
Bone Marrow Transplant Program, University of Colorado Health Sciences Center, Denver 80262, USA.
D000068:Accreditation; D001782:Blood Donors; D003586:Cytomegalovirus Infections / Q000175:diagnosis / Q000276:immunology; D018380:Hematopoietic Stem Cell Transplantation / Q000592:standards*; D006801:Humans; D011785:Quality Assurance, Health Care; D014481:United States; D014486:United States Food and Drug Administration