FDA Announces New Initiative To Regulate Clinical Trials

WASHINGTON, D.C. - The FDA said it has initiated new policy and regulatory developments to strengthen the agency's oversight and protection of patients in clinical trials.

In a June 26 statement, the FDA said the Human Subject Protection and Bioresearch Monitoring (HSP /BIMO) Initiative will "strengthen the integrity of resulting data in an effort to modernize the agency's approach to bioresearch monitoring as part of the Critical Path Initiative."

According to the FDA, BIMO aims to protect human subjects and data integrity in clinical trials. The Initiative will encompass devices, foods, human drugs, biological drug products and veterinary medicine, the …