Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Center for Biologics Evaluation and Research (CBER)

Center for Biologics Evaluation and Research (CBER)

                        CBER Offices & Divisions
          CBER Vision & Mission
          CBER Reports
          CBER Ombudsman
          CBER Product Jurisdiction
          Jobs at the Center for Biologics Evaluation and Research (CBER) Home
          About FDA
          FDA Organization
          Center for Biologics Evaluation and Research (CBER)
          Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER RegulatesCenter for Biologics Evaluation and Research (CBER) Frequently Asked Questions about the Center for Biologics Evaluation and Research (CBER) and the Products CBER Regulates
  
  	
    Share
    Post
    Linkedin

    Email
    PrintCBER 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

CBER Responsibilities Questions and Answers
	What Are Biologics Questions and AnswersBlood

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 AnswersCounter Terrorism

Countering Bioterrorism Questions and AnswersHIV & AIDS

Testing for HIV
	OraQuick Rapid HIV-1 Antibody Test Questions and AnswersImport & Export

Importing CBER-Regulated Products into the United States
	Information on the Use of AntivenomsTissue

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

                                                                                  Content current as of:
      05/11/2023Center for Biologics Evaluation and Research (CBER)

          
                        CBER Offices & Divisions
          CBER Vision & Mission
          CBER Reports
          CBER Ombudsman
          CBER Product Jurisdiction
          Jobs at CBER
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop