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 Research
Office of Communication, Training & Manufacturers Assistance
800-835-4709 or 301-827-1800

Product Approvals

Emergency Use IND Requests

  • For investigational biological products regulated by CBER, call 301-827-2000
  • For all other investigational drugs, call 301-827-4570
  • After working hours, call FDA's Office of Emergency Operations at 301-443-1240

Blood and Blood Products



Safety and Supply

Adverse Event Reporting

Enforcement & Surveillance

General Information

Updated: October 31, 2008