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.
Cellular therapy products include cellular immunotherapies, cancer vaccines, and other types of both autologous and allogeneic cells for certain therapeutic indications, including hematopoetic stem cells and adult and embryonic stem cells. Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use. CBER has approved both cellular and gene therapy products – a list of these products may be found here.
Cellular and gene therapy-related research and development in the United States continue to grow at a fast rate, with a number of products advancing in clinical development. In addition to regulatory oversight of clinical studies, CBER provides proactive scientific and regulatory advice to medical researchers and manufacturers in the area of novel product development.
- Cellular & Gene Therapy Guidances
- Framework for the Regulation of Regenerative Medicine Products
- Application of Current Statuatory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products
- Consolidation of Wound Care Products Containing Live Cells
- Proposed Approach to Regulation of Cellular and Tissue-Based Products
- References for the Regulatory Process for the Office of Tissues and Advanced Therapies
- Regenerative Medicine Advanced Therapy Designation
- Reinventing the Regulation of Human Tissue
- Regenerative Medicine Update: Information for Industry on FDA’s Compliance and Enforcement Policy Regarding Certain Regulatory Requirements
- TRG Rapid Inquiry Program (TRIP)
- Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases
- Testing Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): Specific Requirements
- What is Gene Therapy?
- Approved Cellular and Gene Therapy Products
- Cellular, Tissue, and Gene Therapies Advisory Committee
- Update on Amyotrophic Lateral Sclerosis (ALS) Product Development
- Therapeutic Cloning and Genome Modification
- Resources Related to Regenerative Medicine Therapies
- Compliance Actions (Biologics)
- Safety & Availability (Biologics)
- Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient
- Information About Self-Administration of Gene Therapy
- Letter regarding FDA's regenerative medicine framework and enforcement discretion period for HCT/Ps
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
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