Bioresearch Monitoring

Initial planning under the Bioresearch Monitoring Program called for each testing facility to be inspected yearly. It was later decided that a biennial inspection would suffice to ensure that all 2-year studies would be inspected at least once while in progress. 

First, the people responsible for FDA s bioresearch monitoring program are encouraged by the results of the GLP inspection seen in terms of industry s growing acceptance of the GLPs as a means of establishing a level of reliability for scientific testing. 

U.S. Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs, Bioresearch Monitoring (BIMO), Good Laboratory Practice, Compliance Program 7348.808. 

US FDA. Compliance Program Guidance Manual, Program 7348.808, Chapter 48, Bioresearch Monitoring, Good Laboratory Practice, Completion Date 09/03/93. http //www.fda.gov/ora/compliance ref/bimo/7348 808/48-808.pdf... 

FDA conducts the following three types of inspections through its Bioresearch Monitoring Program (Information Sheets, 1998) ... 

Bioresearch Monitoring (BIMO) Audit of several investigational sites Substantive Review Coordination and Completion in Areas such as... 

Biotechnology Industry Organization British Institute of Regulatory Affairs Biologic License Application Bioresearch Monitoring Branch Body Mass Index Bipolar Affective Disorder... 

The FDA stepped in to assist this evolution after the trial monitoring program in 1972 to 1974. The FDA launched its Bioresearch Monitoring Program in... 

Compliance Program 7348.811 - Bioresearch Monitoring - Clinical Investigators, FDA, 1997. http //www.fda.gov/ora/com-pliance ref/bimo/7348 811/defanlt.htm http //www.fda.gov/ ora/ftparea/compliance/48 811.pdf... 

FDA (1992) Bioresearch monitoring—institutional review boards. In Compliance Program Guidance Manual, Program 7348.809, January, Chapter 48. 

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