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.
To read the full report, please click on the link below.
Newsletter
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
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.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.
