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SFBC International Inc. Data Table V

Table 5: Combined Data Part 2 — FDA IND Studies Conducted by SFBC International Inc. and Approved by the LeeCoast Research Center Institutional Review Board and Independent IRB Inc. ( 1 ).

Source: FDA Bioresearch Monitoring Information System (BMIS) File (current through 2005-09-30). U.S. Food and Drug Administration Division of Scientific Investigations. Available from (External) http://www.fda.gov/cder/foi/special/bmis/index.htm . Accessed 2005-11-15. An asterisk (*) indicates a blank field in Bioresearch Monitoring Information System (BMIS) File. The BMIS file includes information on drug studies conducted under FDA Investigational New Drug (IND) applications only. Bioequivalency studies conducted for generic drug marketing approvals are not included. The final entry in Table 5 for principal investigator Stephen Scheinman M.D. contains an obvious error in the BMIS file Receipt Date field (01-Jan-1900).

Key: FDA Bioresearch Monitoring Information System (BMIS) File fields

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Notes

1. There are 312 entries in Table 5. Each pair of highlighted entries in Table 5 with principal investigator (indicated by DEM in the Type database field) and institutional review board (indicated by IRB in the Type database field) with the same Receipt Date field likely indicates an FDA IND drug study conducted by SFBC International Inc. investigators and reviewed and approved by LeeCoast Research Center Institutional Review Board Inc. or Independent IRB Inc., as indicated. It is not, however, certain. Only sponsors, investigators, and IRBs know for this for certain.

For more information see the Notes to Table 3 .

Independent IRB Inc. is not affiliated with SFBC International Inc.

For the relationship between SFBC International Inc. and the LeeCoast Research Center Institutional Review board, see: SFBC International Inc. Management Team (Phase I/IIA Services). SFBC International Inc. web site. Available from (External) http://www.sfbci.com/sfbc/SFBC/client/en/AboutUs/Management.asp?id=3 . Accessed on 2005-11-25.

It seems likely that the LeeCoast Research Center Institutional Review Board came along with its founder Dr. Phillips when SFBC International Inc. acquired LeeCoast Research Center Inc. There are no records in the Florida Division of Corporations database to indicate the LeeCoast Research Center Institutional Review Board was independently incorporated and it doesn't appear to be registered as a fictitious business name. FDA regulations are silent on the corporate status of institutional review boards. Source: Florida Department of State, Florida Division of Corporations. Available from (External) http://www.sunbiz.org/corpweb/inquiry/search.html . Accessed on 2005-11-25.

This information is intended to be read with the Bloomberg News story titled Big Pharma's shameful secret (With interviews and updates). David Evans, Michael Smith, and Liz Willen. Bloomberg News Special Report. 2005-11-08. Available from (External) http://www.bloomberg.com/specialreport/bigpharma.html , or in PDF from (External) http://www.bloomberg.com/specialreport/pharma.pdf . Accessibility verified 2006-03-28.

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Last Updated: 2006-04-08

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