Consumer / Healthcare Information
CBER is responsible for ensuring the safety and efficacy of blood and blood products, vaccines, allergenics, and biological therapeutics. CBER's regulation of biological products has expanded in recent years to include a wide variety of new products such as biotechnology products, somatic cell therapy and gene therapy, and human cells, tissue and cellular and tissue-based products.
If you have questions or are unable to find the information you need, please contact:
Center for Biologics Evaluation and ResearchProducts
Office of Communication, Training & Manufacturers Assistance
800-835-4709 or 301-827-1800
octma@cber.fda.gov
- Blood FAQs
- Have You Given Blood Lately?
- Keeping Blood Transfusions Safe
- FDA Policy on Blood Donations from Men Who Have Sex with Other Men
- Consumer Frequently Asked Questions (FAQs) - Tissue
- FAQs About Tissue Transplants - (CDC)
- Keeping Human Tissue Transplants Safe
- All About Vaccines for Kids
- Flu Vaccine
- Thimerosal in Vaccines: Frequently Asked Questions
- Vaccine FAQs
- Vaccines Provide Effective Protection
Safety and Supply
- Biological Product Deviation Reporting (includes HCT/P deviation reporting)
- MedWatch
- Transfusion / Donation Related Fatalities
- Vaccine Adverse Event Reporting System
- Clinical Investigator Information
- Compliance and Surveillance
- Violative Advertising & Promotional Labeling Letters
- Warning Letters
- Other Compliance Actions
General Information