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Bioresearch Monitoring Program

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. [Pg.19]

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. [Pg.222]

FDA conducts the following three types of inspections through its Bioresearch Monitoring Program (Information Sheets, 1998) ... [Pg.135]

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... [Pg.236]

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. [Pg.82]

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... [Pg.847]

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... [Pg.83]

FDA (1992) Bioresearch monitoring—institutional review boards. In Compliance Program Guidance Manual, Program 7348.809, January, Chapter 48. [Pg.94]


See other pages where Bioresearch Monitoring Program is mentioned: [Pg.44]    [Pg.613]    [Pg.14]    [Pg.205]    [Pg.128]    [Pg.4]    [Pg.242]    [Pg.44]    [Pg.613]    [Pg.14]    [Pg.205]    [Pg.128]    [Pg.4]    [Pg.242]    [Pg.69]    [Pg.643]    [Pg.83]    [Pg.94]    [Pg.36]   
See also in sourсe #XX -- [ Pg.128 ]

See also in sourсe #XX -- [ Pg.4 , Pg.5 , Pg.6 ]

See also in sourсe #XX -- [ Pg.236 ]




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