ABSTRACT
Pharmaceutical Research and Development (R&D) is a highly regulated industry. In order to allow for any new drug, biologic, or device to be approved for public use, the regulatory agency must go through an intensive scientific review and regulatory inspection. In the United States, the Food and Drug Administration (FDA) is the regulatory agency. Nearly 25 cents of every dollar spent by Americans are on products that are regulated by the FDA. Other regulatory agencies throughout the world include the Therapeutic Products Directorate (TPD) in Canada, the European Medicines Agency (EMA) in the European Union, and the Pharmaceutical and Medical Devices Agency (PMDA) in Japan. Among these agencies, the FDA was the first to require evidence of efficacy obtained from clinical trials. Thus, it is of interest to review a brief history of FDA.
