Bioresearch Monitoring Program Coordination
Background
Last Update: April 10, 2007
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.
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