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, as well as, to provide for protection of the rights and welfare of the thousands of human subjects involved in FDA regulated research.  It has become a cornerstone of the FDA preapproval process for new medicines, medical devices, food and color additives and veterinary products introduced to the U.S. consumer.

The program is implemented domestically and internationally through four multi-center compliance programs resulting in over 1000 inspections annually.  These compliance programs address inspections of nonclinical testing labs (GLP), clinical investigators (GCP), sponsors/monitors and institutional review boards (IRB).

The BIMO program is unique in the scope of its compliance programs and regulations which are shared by all five centers. 

The program also has international and interagency components.The Bioresearch Monitoring Program Coordinator, located organizationally within the Office of Regulatory Affairs, under the Office of Enforcement, Division of Compliance Policy is responsible for overall coordination of the BIMO program.

Program Coordinator

Contact

Robert Hummel
Division of Compliance Policy, Office of Enforcement,
Office of Regulatory Affairs, Food and Drug Administration
Voice: (301) 796-4510
Email: robert.hummel@fda.hhs.gov
Mail: Robert Hummel, Food and Drug Administration, Office of Regulatory Affairs, Office of Enforcement, Division of Compliance Policy, Element Building, 12420 Parklawn Drive, Room 4152, Rockville, MD 20857