ABSTRACT

Clinical research in the United States involving investigational agents is strictly regulated by the Food and Drug Administration (FDA). Historically, the regulations evolved out of necessity and in response to tragedy (refer to reference by McCarthy for further information). A persistent theme during the early attempts at developing federal regulations was the inability of the FDA to enforce the regulations-there were no legal means to inspect manufacturers or to bring disciplinary action. Today, the FDA has the authority to inspect and bring criminal action against violators of regulatory requirements for the manufacture and sale of food, drugs, and cosmetics.