Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER Regulates
CBER regulates an array of diverse and complex biological products, both investigational and licensed, including: allergenics, blood and blood components, medical devices and tests, gene therapy, human tissues and cellular products, vaccines, and xenotransplantation products.
About CBER
Blood
- Bar Code Label Requirements for Blood and Blood Components Questions and Answers
- Bovine Spongiform Encephalopathy (BSE) Questions and Answers
- Roche Molecular Systems COBAS Ampliscreen HBV Test Implementation Questions and Answers
- Variant Creutzfeldt-Jakob Disease (vCJD) and Factor VIII (pdFVIII) Questions and Answers
- Variant Creutzfeldt-Jakob Disease (vCJD) and Factor XI (pdFXI) Questions and Answers
- Variant Creutzfeldt-Jakob Disease (vCJD) and Plasma Derivatives Other than Factor VIII (pdFVIII) Questions and Answers
Counter Terrorism
HIV & AIDS
Import & Export
Tissue
- Good Tissue Practice (CGTP) Final Rule Questions and Answers
- Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing; and Related Labeling 6/19/2007 Final Rule Questions and Answers
- Donor Eligibility Final Rule and Guidance Questions and Answers
- Tissue and Tissue Product Questions and Answers
Vaccines
- Bovine Derived Materials Used in Vaccine Manufacturing Questions and Answers
- Bovine Spongiform Encephalopathy (BSE) Questions and Answers
- FluMist Quadrivalent (Influenza Virus Vaccine Live, Intranasal) Questions and Answers
- H5N1 Influenza Virus Vaccine Questions and Answers
- RotaTeq (Rotavirus Vaccine) Questions and Answers
- Smallpox
- Thimerosal in Vaccines Questions and Answers
- Vaccine Adverse Event Reporting System (VAERS) Questions and Answers
- Vaccines and Variant CJD (vCJD) Questions and Answers
- Vaccine Safety Questions and Answers
- Zostavax (Herpes Zoster Vaccine) Questions and Answers