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Human Biological Products
International Activities

Within FDA, the Center for Biologics Evaluation and Research (CBER) stands at the forefront of biomedical regulatory and research endeavors. The mission of the Center is to protect and enhance the public health through regulation of biological and related products including blood, vaccines, and biological therapeutics according to statutory authorities. The regulation of these products is founded on science and law to ensure their safety, purity, potency, efficacy, and availability.

CBER discharges its regulatory responsibilities through an array of activities, including the review, licensure and inspection of biological products and their manufacturing sites; monitoring preclinical and clinical testing of new biological products; conducting post- marketing surveillance of products; conducting AIDS-related activities, including research on AIDS therapeutic products, diagnostic tests, and vaccines; licensing plasmapheresis centers and blood banks; conducting research to establish product standards and improve testing methods; and collaborating with international organizations (e.g. WHO, ICH) to harmonize biological standards.

Most biological products are derived from living organisms, and include:

• blood and blood products;
• therapeutic products (including those produced by biotechnology, such as cytokines, growth factors, hematologic products, cellular and gene therapy, and monoclonal antibodies); and
• vaccines (including viral and bacterial vaccines, toxins, antitoxins, and allergenic products).

CBER's international activities are coordinated by the International Affairs Advisor in the Office of the Center Director.

Frequently Asked Questions

• How do I file an application for a vaccine, therapeutic or blood product?
• Which products and procedures are regulated by CBER? For example, who regulates blood screening kits for HIV or hepatitis?
• Who should I contact for FDA's biologics harmonization efforts?
• Where can I obtain an agenda for the next advisory committee meeting?
• How do I get information on FDA regulatory actions, e.g., alerts and recalls?

For information on products regulated by CBER, foreign governments and international organizations should contact Joan Wilmarth Blair, International Affairs Advisor:

• Telephone: 301-827-0639
• FAX: 301-827-0644
• email: blair@cber.fda.gov

Industry inquiries should be directed to the Office of Communication, Training and Manufacturers Assistance:

• Telephone: 301-827-1800
• FAX: 301-594-1938
• email: matt@cber.fda.gov

How do I obtain a Certificate for Export?

Certificates for Export can be obtained from the Division of Case Management, Office of Compliance, CBER, 1401 Rockville Pike, Attn: HFM-624, Rockville, MD 20852-1448 U.S.A.:

• Telephone: 301-827-2000
• FAX: 301-594-0940.

RESOURCES

Many CBER documents, including guidelines, points to consider and blood memos, are available on the web.

VAERS Database - the Vaccine Adverse Event Reporting System (VAERS) is a joint CBER/CDC system that accepts all reports of suspected adverse events after the administration of any U.S. licensed vaccine. Adverse events for non-vaccine products should be reported on the MEDWatch form.

The Office of Communications, Training, and Manufacturers' Assistance, CBER, has established three automated e-mail lists to distribute information within CBER and to the public.

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FDA Office of International Programs