Bioresearch Monitoring Program Information
FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications, as well as, to provide for protection of the rights and welfare of the thousands of human subjects and animals involved in FDA regulated research. It has become a cornerstone of the FDA preapproval process for new medicines, medical devices, food and color additives, veterinary products and, tobacco products introduced to the U.S. consumer.
The BIMO program also takes part in pharmacovigilance activities for postmarketing drug products. These activities serve to detect, understand, and prevent drug-related problems.
The program is implemented domestically and internationally through eleven multi-center compliance programs resulting in over 1000 inspections annually. These compliance programs address inspections of nonclinical testing laboratories in accordance with Good Laboratory Practice (GLP), clinical investigators in accordance with Good Clinical Practice (GCP), sponsors/Contract Research Organizations (CROs)/clinical trial monitors, in vivo bioequivalence facilities, institutional review boards (IRBs), radioactive drug research committees, postmarketing adverse drug experience reporting (PADE), and risk evaluation and mitigation strategies reporting (REMS).
The BIMO program is unique in the scope of its compliance programs and regulations which are shared by all six of FDA's Centers (CBER, CDER, CDRH, CFSAN, CTP, and CVM).
The program also has international and interagency components. The Bioresearch Monitoring Program Director, located organizationally within FDA's Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Bioresearch Monitoring Operations (OBIMO), is responsible the overall execution of ORA’s BIMO Program.