The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
HIV and the Blood Supply: An Analysis of Crisis Decisionmaking
Review was renamed the Center for Biologics Evaluation and Research (Fratantoni 1994).
The Center for Biologics Evaluation and Research (CBER) administers regulation of biological products under the biological product control provisions of the Public Health Service Act and applicable provisions of the Food, Drug, and Cosmetics Act. CBER plans and conducts research related to the development, manufacture, testing, and use of both new and old biological products to develop a scientific base for establishing standards designed to ensure the continued safety, purity, potency, and efficacy of biological products. It also coordinates with the Center for Drug Evaluation and Research regarding activities for biological drug products, including research, compliance, and product review and approval. CBER also plans and conducts research on the preparation, preservation, and safety of blood and blood products; the methods of testing safety, purity, potency, and efficacy of such products for therapeutic use; and the immunological problems concerned with products, testing, and use of diagnostic reagents employed in grouping and typing blood.
The CBER is the dominant focus for coordination of the Acquired Immune Deficiency Syndrome (AIDS) program, works to develop an AIDS vaccine and AIDS diagnostic tests, and conducts other AIDS-related activities. It inspects manufacturers' facilities for compliance with standards, tests products submitted for release, establishes written and physical standards, and approves licensing of manufacturers to produce biological products. In carrying out these functions, the CBER cooperates with other Public Health Service organizations, governmental and international agencies, volunteer health organizations, universities, individual scientists, nongovernmental laboratories, and manufacturers of biological products.
Blood Products Advisory Committee
The FDA makes extensive use of technical advisory committees in the support if its evaluation and regulation of drugs, biologics, and medical devices for human use. Advisory committees are utilized by the FDA to obtain independent scientific and technical advice, opinions, or recommendations on a specific matter (FDA 1994). FDA advisory committees can be established in four ways: by order of the President of the United States; by congressional statute, by the Secretary of Health and Human Services, or by the FDA commissioner. The Secretary or the FDA commissioner must approve the establishment, renewal or rechartering, or amendment of all FDA public advisory committee charters (FDA 1994). Generally, the commissioner has direct authority to charter scientific and technical advisory committees, while the Secretary issues charters for committees advising on policy issues. All public