The Cellular, Tissue and Gene Therapies Advisory Committee — formerly called the Biological Response Modifiers Advisory Committee — reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies, and xenotransplantation products that are intended for transplantation, implantation, infusion, and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or replacement of tissues for various conditions. Members of the committee include authorities knowledgeable in the fields of cellular therapies, tissue transplantation, hematology/oncology, and human tissues and transplantation, among other specialties.
FDA Approves Gene Therapy for Glycogen Storage Disease
August 24, 2026
FDA Publishes Two CGT Product Development Guidances
August 19, 2026
FDA Publishes Agenda for Roundtable on Blood Manufacturing and Supply Chain
August 19, 2026