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Clinical Investigators - Disqualification Proceedings

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Clinical Investigators - Disqualification Proceedings


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   No. of Records Found:  230
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.



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