Compliance and Enforcement
Regulatory Activities
Clinical Investigators - Disqualification Proceedings
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Name Center Status Date of status Date NIDPOE Issued Date NOOH Issued Link to NIDPOE Letter Link to NOOH Letter Singleton, Charles M., MD
CDER
Not Disqualified
04/22/2008
04/02/1997
PDF Text Nukta, Emad Dean, MD
CDRH
Restrictions Removed
03/26/2008
09/30/2004
PDA Text
Daley, Patrick J., MD
CBER
Disqualified
03/14/2008
06/23/2003
02/04/2004
PDF Text
PDF Text Rossner, Stephen D., MD
CDER
Disqualified
02/21/2008
05/10/2006
PDF Text
Agus, Bertrand, MD
CDER
Disqualified
02/12/2008
09/27/2007
PDF Text
Cohen, Gary A., MD
CDER
Restrictions Removed
01/04/2008
08/17/2004
PDF Text
Overlie, Paul A., MD
CDRH
Not Disqualified
10/12/2007
07/31/2007
PDF Text
Batshaw, Mark L., MD
CBER
Restrictions Removed
10/01/2007
Kapner, Jamie, MD
CDER
Disqualified
09/10/2007
08/15/2007
PDF Text
Summers, William K., MD
CDER
Restrictions Removed
07/24/2007
05/04/1989
Bigg, Daniel, MD
CBER
Disqualified
05/18/2007
01/24/2007
PDF Text
Riba, Arthur, MD
CDER
Restrictions Removed
11/29/2006
05/19/1999
02/17/1999
PDF
PDF Text Law, Peter K., PhD
CBER
Disqualified
10/23/2006
06/30/2000
11/01/2002
PDF
PDF Text Phillips, Christopher M.
CDER
Disqualified
10/11/2006
01/20/2006
PDF Text
Togias, Alkis, MD
CDER
Restrictions Removed
09/26/2006
Gaman, Walter N., MD
CDER
Restrictions Removed
07/31/2006
10/23/2002
PDF Text
Wholey, Mark H., MD
CDRH
Restricted
07/19/2006
10/21/2005
PDF Text
Caldwell, Jacques R., MD
CDER
Restricted
05/11/2006
06/10/2004
03/08/2006
PDF Text
PDF Text Hagaman, Martha H., MD
CDER
Restricted
01/09/2006
03/01/2005
PDF Text
Offenberg, Howard L., MD
CDER
Restricted
11/28/2005
06/08/2004
PDF Text
McLeod, Jeffrey L., MD
CDER
Disqualified
09/29/2005
08/24/2005
PDF Text
Katz, Lois Anne, MD
CDER
Restrictions Removed
08/21/2005
08/21/2000
PDF
Farber, Harold F., MD
CDER
Disqualified
07/18/2005
Faxon, David P., MD
CDER
Restrictions Removed
06/19/2005
04/07/2000
Text
Swanson, Todd V., MD
CDRH
Restricted
04/10/2005
05/05/2004
PDF Text
Raper, Steven, MD
CBER
Restricted
02/10/2005
Wilson, James M., MD, PhD
CBER
Restricted
02/09/2005
11/30/2000
02/08/2002
PDF
PDF Text Redd, Burton L., MD
CDRH
Restricted
02/08/2005
03/11/2004
PDF Text
Briggs, Richard R., MD
CDRH
Restricted
02/08/2005
03/09/2004
PDF Text
Anderson, Roger D., MD
CDER
Disqualified
01/10/2005
09/13/2000
PDF Text
Marcus, Eugenia, MD
CBER
Disqualified
10/03/2004
04/22/2004
PDF Text
Sawaya, Mary E., MD, PhD
CDER
Disqualified
05/19/2004
DeAbate, Carl Andrew, MD
CDER
Disqualified
02/05/2004
04/13/2001
11/28/2003
PDF Text
PDF Text Mathew, Chavaramplakil P., MD
CDER
Disqualified
09/24/2003
06/27/2001
06/03/2002
PDF Text
PDF Text Williams, Joseph L., MD
CDER
Restrictions Removed (reinstated by correspondence)
05/15/2003
07/01/1998
PDF
Page, Roy C., MD
CBER
Disqualified
04/04/2003
04/06/2000
01/08/2002
PDF
PDF Text Norman, Allyn M., DO
CDER
Disqualified
12/12/2002
06/27/2002
PDF Text
Allman, Richard M., MD
CDER
Restrictions Removed
09/01/2002
07/10/1998
06/28/1999
PDF Text
PDF Text Caro Acevedo, Eduardo, MD
CDER
Disqualified
07/30/2002
08/28/1998
08/18/1999
PDF Text
PDF Text Quarles, Carey L., PhD
CVM
Disqualified
07/29/2002
08/14/1998
LaHaye, Leon C., MD
CDRH
Disqualified
06/18/2002
05/11/2001
01/08/2002
PDF Text
PDF Text Vriesendorp, Huibert M., MD, PhD
CBER
Disqualified
12/31/2001
11/19/1996
09/19/1997
Halikas, James A., MD
CDER
Disqualified
01/17/2001
11/04/1996
04/02/1997
PDF Perez, George, MD
CDER
Restrictions Removed
02/18/2000
10/05/1989
Sparkuhl, Alexander, MD
CDER
Restricted
08/11/1999
07/01/1998
PDF
Fiddes, Robert A., MD
CDER
Disqualified
06/01/1999
09/12/1997
04/07/1998
PDF Tonkon, Melvin, MD
CDER
Not Disqualified
03/30/1999
12/23/1998
Grecu, Eugene O., MD, PhD
CDER
Disqualified
03/25/1999
05/15/1992
10/14/1994
Diamond, Bruce I., PhD
CDER
Disqualified
02/10/1999
Najarian, John S., MD
CBER
Restrictions Removed
11/17/1998
02/23/1993
12/30/1993
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1. Under regulations in effect until 1987, investigators who met the standard for disqualification (repeated or deliberate failure to comply with applicable requirements) could potentially avoid disqualification and continue to be eligible to receive investigational products if they could provide FDA with adequate assurances of future compliance with requirements applicable to the use of investigational drugs and biologics. The provisions for adequate assurances are no longer in the regulations.