| | CBER regulates an array of diverse and complex biological products, both investigational and licensed, including: - Allergenics
Patch tests used to diagnose the causes of contact dermatitis. Extracts used to diagnose and treat rhinitis ("hay fever"), allergic sinusitis and conjunctivitis, and bee stings.
- Blood
Blood and blood components used for transfusion, such as red blood cells, plasma, and platelets. Pharmaceutical products made from blood, such as clotting factors and immunoglobuilns.
- Devices
Medical devices and tests used to safeguard blood, blood components, and cellular products from HIV, hepatitis, syphilis, and other infectious agents. Reagents used to type blood. Machines and related software used to collect blood and blood components.
- Gene Therapy
Gene therapy products that replace a person's faulty or missing genetic material. Gene therapy research could lead to new treatments for cancer cystic fibrosis, heart disease, hemophilia, diabetes, and infectious diseases such as AIDS.
- Human Tissues and Cellular Products
Human tissues for transplantation, such as skin, tendons, ligaments, and cartilage. Cellular products, such as human stem cells and pancreatic islets. Tissue and cellular products have the potential to treat cancer, Parkinson's disease, hemophilia, anemia, diabetes, and other serious conditions.
- Vaccines
Vaccines used for the prevention of infectious diseases, such as mumps, measles, chicken pox, diphtheria, tetanus, influenza, hepatitis, smallpox, and anthrax. Vaccines under development to treat HIV, and to treat or prevent non-infectious conditions, including various cancers.
- Xenotransplantation Products
Xenotransplantation products use live animal cells, tissues, or organs to treat human diseases such as liver failure and diabetes, where human materials are not always available.
|
