ABSTRACT
Federal regulation of biological products (or simply ‘‘biologics’’) is paradoxical in that biologics encompass some of the most advanced, cutting edge medical technology, yet they are regulated in significant part under the framework of the oldest U.S. law governing therapeutic products. For a variety of scientific, historical, legal, and political reasons, the federal regulatory scheme for biological products has been, and to some extent remains, fragmented and unsettled. For example, the fact that, legally speaking, most biologics also meet the statutory definitions for other product classes (i.e., drugs, medical devices) has
resulted in the U.S. Food and Drug Administration (FDA) approving and regulating different types of biologics in all of its organizational Centers [the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM)], with some products being regulated in different respects by more than one Center simultaneously.
