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Clinical Investigators - Disqualification Proceedings

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Clinical Investigators - Disqualification Proceedings


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   No. of Records Found:  232
Name Center Status Date of status Date NIDPOE Issued Date NOOH Issued Link to NIDPOE Letter Link to NOOH Letter
Gelfand, Michael C., MD Burea Not Disqualified 09/11/1981
Lippmann, Maurice, MD Burea Reinstated – Adequate Assurances1 11/05/1984
Steen, Stephen N., MD Burea Not Disqualified – Adequate Assurances1 09/05/1985
Mok, Martin S., MD Burea Not Disqualified – Adequate Assurances1 03/23/1983
Daley, Patrick J., MD CBER Disqualified 03/14/2008 06/23/2003 02/04/2004 PDF Text PDF Text
Kim, Christopher M., MD CBER Not Disqualified 10/20/1993 03/23/1993
Kornblith, Paul, MD CBER Disqualified 11/25/1991 05/29/1991
Lasala, Gabriel Perez, MD CBER Restricted 07/16/2013 02/16/2012 PDF Text
Law, Peter K., PhD CBER Disqualified 10/23/2006 06/30/2000 11/01/2002 PDF PDF Text
Lieberman, Ellin, MD CBER Disqualified 10/12/1993 02/23/1993
Lofgren, David Nils, MD CBER Disqualified 04/28/2008 11/09/2007 PDF Text
Marcus, Eugenia, MD CBER Disqualified 10/03/2004 04/22/2004 PDF Text
McCracken, Elbert, MD CBER Disqualified 05/03/1977 07/12/1976 10/27/1976
McGee, J Michael, MD CBER Disqualified 01/08/2009 06/21/2001 05/21/2002 PDF PDF Text
Mittelman, Abraham, MD CBER Restrictions Removed 12/09/1995 08/11/1993 12/27/1993
Najarian, John S., MD CBER Restrictions Removed 11/17/1998 02/23/1993 12/30/1993
Niederman, Alan, MD CBER Restrictions Removed 07/25/2014 11/01/2010 PDF Text
Page, Roy C., MD CBER Disqualified 04/04/2003 04/06/2000 01/08/2002 PDF PDF Text
Raper, Steven, MD CBER Restricted 02/10/2005
Roberts, William S., MD CBER Disqualified 07/18/1991 05/14/1991
Richards, Jon, MD CBER Restrictions Removed 05/12/2016 08/28/2012 PDF Text
Runels, Jr., Charles E., MD CBER Disqualified 08/06/2009 08/27/2008 02/13/2009 PDF Text PDF
Slazinski, Leonard, MD CBER Disqualified 08/28/1991 05/14/1991
Spencer, Wayne E., MD CBER Disqualified 05/09/2011 04/20/2011 PDF Text
Tewari, Anand, MD CBER Disqualified 11/18/1993 03/23/1995
Vriesendorp, Huibert M., MD, PhD CBER Disqualified 12/31/2001 11/19/1996 09/19/1997
Chang, Alfred E., MD CBER Disqualified 04/07/2010 11/06/2002 10/09/2003 PDF Text PDF Text
Bigg, Daniel, MD CBER Disqualified 05/18/2007 01/24/2007 PDF Text
Wilson, James M., MD, PhD CBER Restricted 02/09/2005 11/30/2000 02/08/2002 PDF PDF Text
Batshaw, Mark L., MD CBER Restrictions Removed 10/01/2007
Berger, Michael Dean, MD CBER Disqualified 06/20/2014 09/26/2011 12/18/2012 PDF PDF
Ziering, William H., MD CDER Disqualified 05/20/2008 11/06/1998 08/16/1999 PDF PDF Text
Allman, Richard M., MD CDER Restrictions Removed 09/01/2002 07/10/1998 06/28/1999 PDF Text PDF Text
Anderson, Roger D., MD CDER Disqualified 01/10/2005 09/13/2000 PDF Text
Aronow, Wilbert S., MD CDER Totally Restricted 10/28/1982
Aroonsakul, Chaovanee, MD CDER Disqualified 10/16/1991 11/24/1989
Balin, Howard, MD CDER Disqualified 03/19/1975
Baratta, Vincent J, MD CDER Disqualified 11/13/1985
Bazo, Albert J., MD CDER Restricted 11/04/1981 11/04/1981
Bender, Sheldon R., MD CDER Disqualified 02/17/1969
Berger, Daniel S., MD CDER Restrictions Removed 09/10/2014 11/27/2009 PDF
Blunck, Jr., Carl E., MD CDER Disqualified 07/07/1979
Borison, Richard L., MD CDER Disqualified 11/10/1998
Bowling, Chetwynd E., MD CDER Disqualified 11/13/1980
Boyles, Paul W., MD CDER Disqualified 04/13/1995 07/10/1990 04/26/1991
Browne, Brian, MD CDER Restrictions Removed 12/23/1997 12/23/1992
Bruschi, Walter C., MD CDER Totally Restricted 06/28/1983
Bushnell, Walter J., MD CDER Disqualified 09/16/1988 03/03/1988
Caldwell, Jacques R., MD CDER Restricted 05/11/2006 06/10/2004 03/08/2006 PDF Text PDF Text
Carter, Charles, MD CDER Reinstated 07/29/1969

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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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