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
- 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 Answers
Xenotransplantation
Guidance, 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 - ARCHIVED
Cell and Gene Therapy Products
More Information
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
(800) 835-4709
(240) 402-8010
For Updates on Twitter, follow @fdacber