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.
Blood & Blood Products
Tissue & Tissue Products
Vaccines for Children - A Guide for Parents and Caregivers FDA Webinar on Protecting Your Child's Health Through Safe and Effective Vaccines Webinar on FDA’s Safety Monitoring of Approved Vaccines[ARCHIVED] 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 Thimerosal in Vaccines Questions and Answers Zostavax (Herpes Zoster Vaccine) Questions and Answers
Guidance, Compliance & Regulatory Information
Safety & Availability
Report a Problem to the Center for Biologics Evaluation & Research How to Report Product Problems and Complaints to the FDA 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