Publication: FDA Consumer
Publication Date: 01-NOV-06
Delivery: Immediate Online Access
Author:
Article Excerpt
The Food and Drug Administration has announced new policy and regulatory developments to strengthen the agency's oversight and protection of patients in clinical trials and the integrity of resulting data. The Human Subject Protection and Bioresearch Monitoring (HSP/BIMO) initiative will help modernize the agency's approach to bioresearch monitoring of devices, foods, human drugs, biological drug products, and veterinary medicine.
The initiative is part of a larger effort of the U.S. Department of Health and Human Services to employ recent advances, including genomics and molecular analysis, to bring about more effective development and...
NOTE: All illustrations and photos have been removed from this article.
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