Consumers (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.

Blood & Blood Products

• Questions about Blood
• Have You Given Blood Lately?

Tissue & Tissue Products

• Cord Blood Banking - Information for Consumers
• Questions about Tissues
• Frequently Asked Questions About Tissue Transplants (Centers for Disease Control and Prevention)

Vaccines

• Vaccines for Children - A Guide for Parents and Caregivers
• Questions about Vaccines
• Vaccine Safety Questions and Answers
• Influenza Virus Vaccine Safety & Availability
• Zostavax (Herpes Zoster Vaccine) Questions and Answers

Regenerative Medicine and Related Products

• Important Patient and Consumer Information About Regenerative Medicine Therapies

Guidance, Compliance & Regulatory Information

• Biologics Rules
• Biologics Guidances
• Biologics Post-Market Activities
• Compliance Actions (Biologics)
• Untitled 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

Science & Research

• Science for Consumers

Partnerships/Collaborations

• FDA Launches AATD Pre-Consortium Partnership with C-Path

Contact Us

1-888-INFO-FDA

1-888-463-6332

Food and Drug Administration

Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave
Silver Spring, MD 20993
United States

For Latest Updates Follow

@FDADrugs

The latest information from the Center for Biologics Evaluation and Research.