The Food and Drug Administration's Oversight of Clinical Trials
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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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
