Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials

摘要

The Federal Food, Drug, and Cosmetic Act requires all new investigational drugs and biologics to undergo clinical trials on human subjects (hereinafter referred to as 'subjects') to demonstrate the safety and efficacy of these products prior to approval for sale in the United States. Through its review of the clinical trial protocol and sponsors' marketing applications and its inspections of clinical trial sites, FDA ensures the rights, safety, and well-being of subjects who participate in these trials and verifies that the clinical trial data collected are both accurate and reliable. The objectives of the research are as follows: 1. To determine the extent to which sponsors submitted data from foreign clinical trials to support drug- and biologic-marketing applications approved by the Food and Drug Administration (FDA) in fiscal year (FY) 2008. 2. To determine the extent to which FDA monitors and inspects foreign clinical trials that support marketing applications.