FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits 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, just recently, new tobacco products introduced to the U.S. consumer.
The program is implemented domestically and internationally through seven 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, and institutional review boards (IRBs).
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, CVM).
The program also has international and interagency components. The Bioresearch Monitoring Program Coordinator, located organizationally within FDA's Office of Global Regulatory Operations and Policy (OGROP), Office of Regulatory Affairs (ORA), Office of Policy and Risk Management (OPRM), Medical Products and Tobacco Policy Staff (MPTPS), is responsible the coordination of policy related to the BIMO Program.
Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs, US Food and Drug Administration
Voice: (301) 796-3899
Email: [email protected]
Mail: Hector Colon, US Food and Drug Administration, Office of Regulatory Affairs, Office of Bioresearch Monitoring Operations, 12420 Parklawn Drive, ELEM RM2135, Rockville, MD 20857