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Cellular and Gene Therapy Products


Cellular therapy products include cellular immunotherapies, and other types of both autologous and allogeneic cells for certain therapeutic indications, including adult and embryonic stem cells.

Human gene therapy refers to products that introduce genetic material into a person's DNA to replace faulty or missing genetic material, thus treating a disease or abnormal medical condition.

The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.