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Article: FDA Oversight Of Clinical Trials.( Food and Drug Administration)
- Article from:
- Mondaq Business Briefing
- Article date:
- October 23, 2007
CopyrightCOPYRIGHT 2007 Mondaq Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Office of the Inspector General issues recommendations on FDA investigation processes and regulations.
On September 28, 2007, the Office of the Inspector General for the Department of Health and Human Services (OIG) released a report entitled "The Food and Drug Administration's Oversight of Clinical Trials" (the Report). The OIG issued the Report pursuant to a congressional request to review oversight of clinical trials by the U.S. Food and Drug Administration (FDA) after a series of news articles detailed vulnerabilities in enforcement and monitoring of clinical trials in humans (For example, see David Evans et al., Drug Industry Human Testing Masks Death, ...