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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
Kleber, Ronald, MD CDER Disqualified 08/06/1981 07/16/1980 12/04/1980
Klein, Donald F., MD CDER Not Disqualified – Adequate Assurances1 03/14/1986
Kligman, Albert M., MD CDER Reinstated 08/19/1966
Kline, Nathan S., MD CDER Disqualified 11/13/1980
Knapp, Richard B., MD CDER Disqualified 11/04/1982 03/12/1982
Kornblith, Paul, MD CBER Disqualified 11/25/1991 05/29/1991
Kostas, Constantine I., MD CDER Disqualified 10/07/1986
Kumar, Anil, MD CDER Not Disqualified 05/02/2014 PDF
Kurland, Morton L., MD CDER Disqualified 11/06/1978
LaHaye, Leon C., MD CDRH Disqualified 06/18/2002 05/11/2001 01/08/2002 PDF Text PDF Text
Lamphier, Timothy A., MD CDER Disqualified 02/14/1979
Lapolla, Anthony, MD CDER Disqualified 05/05/1969
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
Levin, Harvey M., MD CDER Disqualified 02/01/1980
Levinson, Robert A., MD CDER Disqualified 03/31/1988
Levitt, Martin, MD CDER Restrictions Removed 05/02/1989
Lichty, Charles P., MD CDER Disqualified 12/23/2016
Lieberman, Ellin, MD CBER Disqualified 10/12/1993 02/23/1993
Linker, Charles A., MD CDER Restrictions Removed 05/18/1989 03/31/1988
Lippmann, Maurice, MD Burea Reinstated – Adequate Assurances1 11/05/1984
Lofgren, David Nils, MD CBER Disqualified 04/28/2008 11/09/2007 PDF Text
Loucks, David Craig, MD CDER Restricted 08/16/2010 08/18/2009 PDF Text
Lowe, Leo, MD CDER Disqualified 10/18/1966
Lu, Eugene, MD CDER Restricted 07/08/2010 03/16/2010 PDF Text
Macapinlac, Manuel, MD CDER Disqualified 08/26/2010 02/23/2009 04/19/2010 PDF Text PDF Text
Marcus, Eugenia, MD CBER Disqualified 10/03/2004 04/22/2004 PDF Text
Marker, Howard W., MD CDER Disqualified 10/08/2009 01/29/2009 PDF Text
Marquez, Farid, MD CDER Disqualified 08/06/2015 06/26/2015 PDF
Mathew, Chavaramplakil P., MD CDER Disqualified 09/24/2003 06/27/2001 06/03/2002 PDF Text 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
McHardy, Gordon, MD CDER Reinstated 01/27/1969
McLeod, Jeffrey L., MD CDER Disqualified 09/29/2005 08/24/2005 PDF Text
Mendolia, Thomas Francis, DO CDER Disqualified 01/14/2014 11/22/2011 03/18/2013 PDF Text Text
Minton, Keith M., DO CDER Disqualified 01/26/1993
Mittelman, Abraham, MD CBER Restrictions Removed 12/09/1995 08/11/1993 12/27/1993
Mok, Martin S., MD Burea Not Disqualified – Adequate Assurances1 03/23/1983
Morton, Robert E., MD CDER Restricted 08/18/1988
Moskowitz, George, MD CDER Restrictions Removed 01/31/1986 05/20/1982
Musty, Richard E., MD, PhD CDER Restricted 09/20/1990 06/05/1990
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
Norman, Allyn M., DO CDER Disqualified 12/12/2002 06/27/2002 PDF Text
Novo, Felipe P., MD CDER Disqualified 11/04/1980
Nukta, Emad Dean, MD CDRH Restrictions Removed 03/26/2008 09/30/2004 PDA Text
Offenberg, Howard L., MD CDER Restricted 11/28/2005 06/08/2004 PDF Text
Ortiz, Julio A., MD CDER Disqualified 12/03/1980
Overlie, Paul A., MD CDRH Not Disqualified 10/12/2007 07/31/2007 PDF Text
Page, Roy C., MD CBER Disqualified 04/04/2003 04/06/2000 01/08/2002 PDF PDF Text

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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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