The Food and Drug Administration's Oversight of Clinical Trials

WASHINGTON, DC, September 28, 2007-The Office of Inspector General (OIG) received a congressional request to review FDA oversight of clinical trials after a series of news articles highlighted vulnerabilities. The OIG aimed to determine the extent to which the Food and Drug Administration (FDA) conducted inspections of clinical trials from fiscal year (FY) 2000 to FY 2005, and to assess FDA’s processes for inspecting clinical trials. They found that data limitations and other factors inhibit FDA’s ability to effectively manage the bioresearch monitoring (BiMo program), and that the FDA inspected approximately 1 % of clinical trial sites during the fiscal year 2000–2005 period.  

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