CBER regulates human gene therapy products. These are products that introduce genetic material into the body to replace faulty or missing genetic material. Gene therapy can be used for treating or curing a disease or abnormal medical condition.
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.
Further information available at:
http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/default.htm
