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U.S. Department of Health and Human Services

Science & Research

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FDA's HSP/BIMO Initiative Accomplishments - Update -- Long Description for Figure 1

Figure 1 is a table of the bioresearch monitoring (BIMO) inspections assigned by all Centers that were actually conducted during fiscal year 2008 (FY 2008) by FDA field investigators in the Office of Regulatory Affairs (ORA).   Inspections conducted are tabulated by Center and by the entity that was inspected.  Total numbers of inspections conducted for each Center and for each entity inspected, across Centers, are also included.

For the Center for Biologics Evaluation and Research (CBER) the following inspections were conducted:

  • Clinical investigators (CIs) – 77
  • Institutional review boards (IRBs) – 19
  • Sponsor/Monitors (Spon/Mon) – 6
  • Good laboratory practice (GLP) – 4
  • Total – 106

For the Center for Drug Evaluation and Research (CDER):

  • CIs – 405
  • IRBs – 72
  • Spon/Mon – 43
  • GLP – 27
  • Bioequivalence (BEQ) – 116; unique to CDER
  • Total – 547 [663 with BEQ]

For the Center for Devices and Radiological Health (CDRH):

  • CIs – 155
  • IRBs – 88
  • Spon/Mon – 57
  • GLP – 1        
  • Total – 301

For the Center for Food Safety and Applied Nutrition (CFSAN):

  • GLP – 1
  • Total – 1

For the Center for Veterinary Medicine (CVM):

  • CIs – 38
  • Spon/Mon – 3
  • GLP – 14
  • (IRBs are not applicable to CVM, as oversee human clinical trials)
  • Total - 55

Totals by inspected entity, across all Centers, are as follows:

  • CIs – 675
  • IRBs – 179
  • Spon/Mon – 109
  • GLP – 47

Total BIMO inspections completed – 1010 [1126 with BEQ]