Chapter 6 - The Regulation of Drugs and Biological Products by the Food and Drug Administration

Abstract

The mission of the Food and Drug Administration (FDA) is to protect and enhance the public health through the regulation of medical products, food, and tobacco and to spur innovation to address unmet medical and public health needs. There are seven product review centers with oversight authority over specific types of products that account for approximately 25% of spending by American consumers each year. This chapter provides an overview of the regulation of human drug and biological products, primarily in the Center for Drug Evaluation and Research and the Center for Biologics Research and Evaluation. FDA regulatory authority over clinical trials for drug and biologic products is to in part ensure human subject protections and data integrity, the cornerstones of good clinical practice. Moreover, the substantial evidence standard required for demonstration of effectiveness in marketing applications greatly impacts the clinical trial design and conduct.