Healthcare Providers (Biologics)
Biological 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 301-796-8240
Blood & Blood Products
Tissue & Tissue Products
Vaccines
Questions about Vaccines Vaccine Safety Questions and Answers Gardasil (Human Papillomavirus Vaccine) Questions and Answers - Gardasil, June 8, 2006 [ARCHIVED]Influenza Virus Vaccine Safety & Availability Importance of Influenza Vaccination for Health Care Personnel La Importancia de la Vacunación para el Personal Relacionado con el Cuidado de la Salud Thimerosal in Vaccines Thimerosal in Vaccines Questions and Answers Zostavax (Herpes Zoster Vaccine) Questions and Answers
Xenotransplantation
Guidance, Compliance & Regulatory Information
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 (PDF - 115KB)Tissue Safety & Availability Vaccine Safety & Availability How to Report Product Problems and Complaints to the FDA Letters to Industry / Healthcare Providers / Clinical Investigators