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.
REGULATORY UPDATE: FDA Issues Draft Guidance to Support CGT Development
November 19, 2024
AABB Accepting Feedback on Cell and Gene Therapy Standards for Pharmacy
November 19, 2024
FDA Approves Direct-to-Brain Gene Therapy for AADC Deficiency
November 14, 2024