Vaccines, Blood & Biologics
Resources for You
Cellular & Gene Therapy Products
The Center for Biologics Evaluation and Research (CBER) regulates human gene therapy products - products that introduce genetic material into the body to replace faulty or missing genetic material, thus treating or curing a disease or abnormal medical condition. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.
FDA has not yet approved any human gene therapy product for sale. However, the amount of gene-related research and development occurring in the United States continues to grow at a fast rate and FDA is actively involved in overseeing this activity. FDA has received many requests from medical researchers and manufacturers to study gene therapy and to develop gene therapy products.
Such research could lead to gene-based treatments for cancer, cystic fibrosis, heart disease, hemophilia, wounds, infectious diseases such as AIDS, and graft-versus-host disease.
Compliance & Enforcement
Gene Therapy Patient Tracking
Genetic Modification Clinical Research Information Sytem (GeMCRIS) (National Institutes of Health) Gene Therapy Patient Tracking System (PDF - 100KB)NIH and FDA Launch New Human Gene Transfer Research Data System (National Institutes of Health) Office of Biotechnology Activities: Recombinant DNA (National Institutes of Health)
Product Development & Approval
Donor Eligibility
Regulatory Information
Application of Current Statuatory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products (PDF - 489KB)Cellular & Gene Therapy Guidances References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies Proposed Approach to Regulation of Cellular and Tissue-Based Products (PDF - 433KB)Reinventing the Regulation of Human Tissue
Spotlight
Recalls & Alerts
Related Information
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448