Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Resumo

The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Matters considered at the meeting will include discussion of the current regulatory expectations for xenotransplantation products. The discussion topics include human cells that have had ex vivo contact with animal cells, and animal organs and cells for transplantation into human subjects, both of which are xenotransplantation products. The meeting will be open to the public on both days. FDA is establishing a docket for public comment on this document.