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J Psychosoc Nurs Men · Jan 2008
ReviewHow are drugs approved? Part 1: the evolution of the Food and Drug Administration.
- Robert H Howland.
- University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, PA 15213, USA. HowlandRH@upmc.edu
- J Psychosoc Nurs Men. 2008 Jan 1;46(1):15-9.
AbstractThe discovery, development, and marketing of drugs for clinical use is a process that is complex, arduous, expensive, highly regulated, often criticized, and sometimes controversial. In the United States, the Food and Drug Administration (FDA) is the governmental agency responsible for regulating the development and marketing of drugs, medical devices, biologics, foods, cosmetics, radiation-emitting electronic devices, and veterinary products, with the objective of ensuring their safety and efficacy. As part of a broad overview of the drug development process, this article will describe the historical evolution of the FDA. This will provide background for two subsequent articles in this series, which will describe the ethical foundations of clinical research and hethe stages of drug development.
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