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FDA's oversight of drug trials is dangerously lax, report says.

Publication: Trial
Publication Date: 01-DEC-07
Format: Online
Delivery: Immediate Online Access

Article Excerpt
The FDA's oversight of volunteers in clinical drug trials is sorely lacking, according to a report from the Office of the Inspector General (OIG) for the Department of Health and Human Services, and the agency is overly reliant on voluntary compliance from drug companies even when the companies' violations of FDA policy are flagrant. The report by Inspector General Daniel Levinson, released in September, was prepared in response to congressional inquiries.

Its findings depict an agency that is disorganized, plagued with poor record-keeping, and unable to monitor subjects in clinical trials with...

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