The Regulatory Landscape

Abstract

The FDA is obligated to protect human subjects and to ensure that data submitted for clinical trials are obtained ethically, scientifically, and without bias. In addition to issuing guidelines for good clinical practice, the FDA conducts compliance oversight of clinical studies in the United States and internationally through an inspection or audit process. A number of factors have led to migration of clinical trials overseas including lengthy recruitment delays, global disease variation, and costs. The FDA has developed a variety of methods to increase the efficiency of the approval process through international outreach, innovative trials, and information technology.