title: How are drugs approved? Part 1: the evolution of the Food and Drug Administration.
abstract: The 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.
authors.affiliation: University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, PA 15213, USA. HowlandRH@upmc.edu
authors.forename: Robert H
authors.initials: RH
authors.lastname: Howland
mesh_terms: D002986:Clinical Trials as Topic; D018795:Device Approval; D017277:Drug Approval / Q000458:organization & administration*; D015507:Drugs, Investigational / Q000009:adverse effects / Q000592:standards; D018166:Health Care Reform / Q000458:organization & administration; D006801:Humans; D040541:Marketing / Q000458:organization & administration; D004366:Nonprescription Drugs / Q000009:adverse effects / Q000592:standards; D009937:Organizational Objectives; D011358:Product Surveillance, Postmarketing; D017751:Safety Management / Q000458:organization & administration; D019966:Substance-Related Disorders / Q000517:prevention & control; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*
chemical_list: D015507:Drugs, Investigational; D004366:Nonprescription Drugs