Federal Register #2026-20989

FDA renews its Cellular, Tissue, and Gene Therapies Advisory Committee

The FDA is renewing its expert advisory committee on cellular, tissue, and gene therapies for an additional two years. - Government buyer: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA); the notice concerns the Cellular, Tissue, and Gene Therapies Advisory Committee. - Purpose and requirements: The committee provides independent advice to the FDA on the safety, effectiveness, and appropriate use of human cells, human tissues, gene therapies, and xenotransplantation products, and makes recommendations to the FDA Commissioner. - Companies mentioned: Replimune, Inc., Capricor, Inc., and AstraZeneca are cited in connection with historical committee reviews; they are not being solicited as vendors. - Procurement status: This is a committee-renewal notice, not a purchase opportunity. No products, services, quantities, or part numbers are requested.

Description

The Food and Drug Administration announces the renewal of the Cellular, Tissue, and Gene Therapies Advisory Committee for an additional two years, with its charter in effect until October 28, 2028. The committee provides expert advice to the Commissioner on the safety, effectiveness, and appropriate use of human cells, human tissues, gene therapies, and xenotransplantation products. It reviews available data and makes recommendations concerning these products and their use in treating disease and repairing or replacing tissues. The notice states that renewal is in the public interest and that the committee’s authority was due to expire on October 28, 2026.

View original listing