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.
Bar Code Label Requirements for Blood and Blood Components Questions and Answers Blood Donations from Men Who Have Sex with Other Men Questions and Answers[ARCHIVED] Bovine Spongiform Encephalopathy (BSE) Questions and Answers Donating Blood Questions and Answers Questions and Answers on FDA Guidance Entitled "Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients" Question and Answer on FDA Guidance Entitled "Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS" Questions and Answers on Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products[ARCHIVED] Roche Molecular Systems COBAS Ampliscreen HBV Test Implementation Questions and Answers[ARCHIVED] 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
Import & Export
Establishment Registration and Listing for Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) Questions and Answers 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
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
Gardasil (Human Papillomavirus Vaccine) Questions and Answers - Gardasil, June 8, 2006[ARCHIVED] H5N1 Influenza Virus Vaccine, manufactured by Sanofi Pasteur, Inc. 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