Strengthening the regulation of clinical trials and bioresearch monitoring.

Abstract

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.