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        Resources for You (Biologics)

Healthcare Providers (Biologics) Home
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              Two doctors talking, one holding a tablet and penBiological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. The Center for Biologics Evaluation and Research (CBER) is responsible for ensuring the safety and efficacy of the biological products.

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application. In rare instances a physician may request an Emergency Use IND for a patient. Contact information for Emergency Use IND Requests:

For investigational biological products regulated by CBER, call 240-402-7800
	For all other investigational drugs, call 301-796-3400 or 1-855-543-3784
	After working hours, call FDA's Office of Emergency Operations at 301-796-8240Blood & Blood Products

Questions about Blood
	Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood
	HIV Home Test KitsTissue & Tissue Products

Questions about Tissues
	Frequently Asked Questions About Tissue Transplants (Centers for Disease Control and Prevention)Vaccines

Questions about Vaccines
	Vaccine Safety Questions and Answers
	Influenza Virus Vaccine Safety & Availability
	Importance of Influenza Vaccination for Health Care Personnel
	La Importancia de la Vacunacion para el Personal Relacionado con el Cuidado de la Salud
	Thimerosal and Vaccines
	Thimerosal in Vaccines Questions and Answers
	Zostavax (Herpes Zoster Vaccine) Questions and AnswersXenotransplantation

Information and Recommendations for Physicians Involved in the Co-Culture of Human Embryos with Non-Human Animal CellsGuidance, Compliance & Regulatory Information

Biologics Rules
	Biologics Guidances
	Biologics Post-Market Activities
	Compliance Actions (Biologics)
	Unititled Letters (CBER)Safety & Availability

Report a Problem to the Center for Biologics Evaluation & Research
	Impact of Severe Weather Conditions on Biological Products
	Recalls (Biologics)
	CBER-Regulated Products: Shortages and Discontinuations
	Blood Safety & Availability
	Investigation of whether the acute hemolysis associated with Rho(D) immune globulin intravenous (human) administration for treatment of immune thrombocytopenic purpura is consistent with the acute hemolytic transfusion reaction model
	Tissue Safety & Availability
	Vaccine Safety & Availability
	How to Report Product Problems and Complaints to the FDA
	Letters to Industry / Healthcare Providers / Clinical Investigators - ARCHIVEDCell and Gene Therapy Products

Frequently Asked Questions about Minimally Manipulated, Unrelated Cord Blood Products for Clinical UseMore Information

For Health ProfessionalsSub-Topic Paragraphs
          Follow CBER
		Division of Communication and Consumer Affairs
			Office of Communication, Outreach and Development
			Center for Biologics Evaluation and Research
			Food and Drug Administration
			10903 New Hampshire Ave WO71-3103
			Silver Spring, MD 20993-0002
		
		ocod@fda.hhs.gov
		
		(800) 835-4709
			(240) 402-8010
		
		For Updates on Twitter, follow @fdacber
	Resources for You (Biologics)
			About the Center for Biologics Evaluation and Research (CBER)
			Report a Problem to the Center for Biologics Evaluation & Research
			Recalls (Biologics)
			CBER-Regulated Products: Shortages and Discontinuations
			Biologics Products & Establishments

                                                                                  Content current as of:
      05/11/2023
                  
                   
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