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SFBC International Related Data Table VI

Table 6: FDA IND Studies Approved by First Foundation for the Protection of Human Subjects in Research, Inc. Institutional Review Board. ( 1 )

Source: FDA Bioresearch Monitoring Information System (BMIS) File (current through 2006-03-31). U.S. Food and Drug Administration Division of Scientific Investigations. Available from (External) http://www.fda.gov/cder/foi/special/bmis/index.htm . Accessed 2006-04-08. 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.

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

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Notes

1. According to the FDA Bioresearch Monitoring Information System (BMIS) File, the First Foundation for the Protection of Human Subjects in Research, Inc. institutional review board reviewed and approved 111 drug studies subject to FDA Investigational New Drug regulations. 44 of the 111 approvals were for drug studies were conducted by Kenneth Lasseter, of Clinical Pharmacology Associates, Inc., a business owned by Kenneth Lasseter, Earl Cooper Shamblen, and Alison Murdoch. The First Foundation for the Protection of Human Subjects in Research, Inc. institutional review board was owned by Alison Murdoch, wife of Earl Shamblen. Alison Murdoch, also known as Alison Madigan, subsequently founded Southern Institutional Review Board, Inc. on 1994-12-27. Clinical Pharmacology Associates, Inc. was dissolved in October, 1989. In November, 1977, Kenneth Lasseter and Earl Shamblen founded Clinical Pharmacology International, Inc., which became a subsidary of SFBC International Inc. in August, 2003. Sources:

First Foundation for the Protection of Human Subjects in Research. Florida Department of State Division of Corporations. Available from (External) http://www.sunbiz.org/scripts/corevt.exe?a1=DETEVE&n1=M26680&n2=DOMP . Clinical Pharmacology Associates, Inc. Florida Department of State Division of Corporations. Available from (External) http://www.sunbiz.org/scripts/cordet.exe?a1=DETFIL&n1=528009&n2=NAMFWD&n3=0000&n4=N&r1=&r2=&r3=&r4=CLINICALPHARMACOLOGYASSOCIAT&r5= . Accessed on 2006-04-09.

Southern Institutional Review Board, Inc. Florida Department of State Division of Corporations. Available from (External) http://www.sunbiz.org/scripts/cordet.exe?a1=DETFIL&n1=P94000093204&n2=NAMFWD&n3=0000&n4=N&r1=&r2=&r3=&r4=SOUTHERNINSTITUTIONALREVIEW&r5= . Accessed on 2006-04-09.

Clinical Pharmacology International, Inc. Florida Department of State Division of Corporations. Available from (External) http://www.sunbiz.org/scripts/cordet.exe?a1=DETFIL&n1=651698&n2=NAMFWD&n3=0000&n4=N&r1=&r2=&r3=&r4=CLINICALPHARMACOLOGYASSOCIAT&r5= . Accessed on 2006-04-09.

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.

Last Updated: 2006-04-28

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