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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
Abruzzi, Jr., William A., MD CDER Disqualified 08/31/1966
Achreja, Manjeet Kaur, MD CDER Disqualified 04/24/2008 08/29/2007 PDF Text
Agus, Bertrand, MD CDER Disqualified 02/12/2008 09/27/2007 PDF Text
Alexander, Elmore, DO CDER Disqualified 08/15/2013 01/27/2012 08/15/2012
Ali, Nayab, MD CDER Restrictions Removed 06/23/1986 08/06/1980 11/12/1981
Allbritton, Allan R., CVM Disqualified 01/24/1997
Allen, Brady L., MD CDER Disqualified 12/11/1990
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
Arata, MD, Michael A. CDRH Disqualified 05/21/2018 09/13/2016 06/21/2017 PDF Text
Aronow, Wilbert S., MD CDER Totally Restricted 10/28/1982
Aroonsakul, Chaovanee, MD CDER Disqualified 10/16/1991 11/24/1989
Baker, James, MD CDER Disqualified 05/01/2018 03/23/2018 PDF
Balin, Howard, MD CDER Disqualified 03/19/1975
Baratta, Vincent J, MD CDER Disqualified 11/13/1985
Batshaw, Mark L., MD CBER Restrictions Removed 10/01/2007
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
Berger, Michael Dean, MD CBER Disqualified 06/20/2014 09/26/2011 12/18/2012 PDF PDF
Bigg, Daniel, MD CBER Disqualified 05/18/2007 01/24/2007 PDF Text
Bilezikian, John P., MD CDER Not Disqualified 11/27/2015 01/12/2015
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
Briggs, Richard R., MD CDRH Restricted 02/08/2005 03/09/2004 PDF Text
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
Calenoff, Emanuel, MD CDER Disqualified 12/18/2015 09/25/2014 04/10/2015 PDF PDF
Candal, Francisco J., MD CDER Disqualified 03/29/2012 03/02/2011 09/29/2011 PDF Text
Caro Acevedo, Eduardo, MD CDER Disqualified 07/30/2002 08/28/1998 08/18/1999 PDF Text PDF Text
Carter, Charles, MD CDER Reinstated 07/29/1969
Carter, Thomas N., MD CDER Disqualified 11/22/1983 09/09/1983
Caruso, Walter A., MD CDER Totally Restricted 07/28/1988
Cass, Leo, MD CDER Disqualified 12/15/1965
Cataldo, Joseph R., MD CDER Totally Restricted 04/14/1982
Chang, Alfred E., MD CBER Disqualified 04/07/2010 11/06/2002 10/09/2003 PDF Text PDF Text
Chaplan, Abraham A., MD CDER Disqualified 02/28/1979
Close, John H., MD CDER Disqualified 07/19/1978
Cohen, Gary A., MD CDER Restrictions Removed 01/04/2008 08/17/2004 PDF Text
Cohn, Cal K., MD CDER Adequate Assurances1 04/17/1991 04/04/1990
Copelan, Herbert W., MD CDER Reinstated 08/19/1966
Corbett III, Bernard A., MD CDER Disqualified 08/07/2014 07/16/2014 PDF
Crane, Daniel L., MD CDER Disqualified 06/27/1984
Cullen, Aubrey P., MD CDER Totally Restricted 06/08/1987
Daley, Patrick J., MD CBER Disqualified 03/14/2008 06/23/2003 02/04/2004 PDF Text PDF Text
Dalton, Fred C., MD CDER Disqualified 01/03/1979 10/18/1978
Davidson, Jeffrey N., DVM CVM Disqualified 07/20/2009 11/07/1997
Day, Phillip L., MD CDER Disqualified 08/28/1975
DeAbate, Carl Andrew, MD CDER Disqualified 02/05/2004 04/13/2001 11/28/2003 PDF Text PDF Text
Diamond, Bruce I., PhD CDER Disqualified 02/10/1999
Doss, Jr., William L., MD CDER Disqualified 06/14/1979 11/15/1977 03/03/1978
Dressler, David M., MD CDER Disqualified 03/14/1984 02/07/1984
Dunlop, Edwin, MD CDER Reinstated 12/24/1970
Edwards, Thomas B., MD CDER Restricted 01/26/1998
Ericsson, Arthur Dale, MD CDER Disqualified 05/04/2009 03/31/2008 03/04/2009 PDF Text PDF Text
Fabre, Louis F., MD, PhD CDER Restricted 06/23/2008 01/19/2005 PDF Text
Farber, Harold F., MD CDER Disqualified 07/18/2005
Faxon, David P., MD CDER Restrictions Removed 06/19/2005 04/07/2000 Text
Feurst, Samuel I., MD CDER Disqualified 10/02/1984 09/23/1983
Fiddes, Robert A., MD CDER Disqualified 06/01/1999 09/12/1997 04/07/1998 PDF
Finnerty, Jr., Frank A., MD CDER Restrictions Removed 12/04/1988 12/04/1985
Fogari, Robert, MD CDER Totally Restricted 04/24/1985
Fox, Jr., Robert A., MD CDER Disqualified 02/15/1989
Franklin, William C., MD CDER Disqualified 11/09/1982 10/20/1981 08/26/1982
Froning, Edward C., MD CDER Disqualified 04/10/1976 07/31/1975
Fuller, Ronald R., DVM CVM Disqualified 01/29/1988 03/11/1986 08/04/1986
Gaman, Walter N., MD CDER Restrictions Removed 07/31/2006 10/23/2002 PDF Text
Gamarra, Miguel H., MD CDER Disqualified 05/31/1983
Garcia, Julio M., MD CDER Restricted 10/19/1995
Garetz, Floyd K., MD CDER Disqualified 11/23/1982
Garfinkel, Barry D., MD CDER Totally Restricted 05/14/1994
Garjian, Peggy Ann, MD CDER Disqualified 09/22/2008 08/25/2008 PDF Text
Gatenby, Robert A., MD CDER Reinstated pursuant to Agreement 02/16/2023 09/25/1988
Gelfand, Michael C., MD Burea Not Disqualified 09/11/1981
Gentry, Layne O., MD CDER Disqualified 06/18/2008 03/23/1998 04/15/1999 PDF PDF Text
Gillespie, Larrian, MD CDER Disqualified 02/02/1989 05/20/1988
Gooding, John M., DO CDER Totally Restricted 11/07/1986 06/19/1984
Grecu, Eugene O., MD, PhD CDER Disqualified 03/25/1999 05/15/1992 10/14/1994
Guerin, Bernard K., MD CDER Disqualified 11/13/1984 07/02/1984
Gupta, Suresh, MD CDER Not Disqualified 06/29/2009 09/12/2008 PDF Text
Guy, Matthew J., MD CDER Disqualified 07/25/2008 01/24/2008 PDF Text
Hagaman, Martha H., MD CDER Restricted 01/09/2006 03/01/2005 PDF Text
Halikas, James A., MD CDER Disqualified 01/17/2001 11/04/1996 04/02/1997 PDF
Hendrick, Kim C., MD CDER Disqualified 12/11/2009 05/11/2006 07/01/2009 PDF Text
Hofmann, Alan F., MD CDER Restricted 11/21/1995
Holland, James A., MD CDER Disqualified 08/25/2008 09/22/2004 08/14/2007 PDF Text
Holmes, Amy S., MD CDER Disqualified 01/11/2011 12/02/2010 PDF Text
Hopkinson, III., John H., MD CDER Not Disqualified – Adequate Assurances 1 06/03/1983
Hotchkiss, Jr., Dwight J., MD CDER Disqualified 06/25/1984
John, Jr., J T., MD CDER Disqualified 11/04/1983
Jolly, Jr., Henry W., MD CDER Restrictions Removed 11/17/1986 11/17/1983
Kapner, Jamie, MD CDER Disqualified 09/10/2007 08/15/2007 PDF Text
Katz, Lois Anne, MD CDER Restrictions Removed 08/21/2005 08/21/2000 PDF
Khooblall, Khem L., MD CDER Disqualified 06/17/1998
Kim, Christopher M., MD CBER Not Disqualified 10/20/1993 03/23/1993
Kirkman Campbell, Maria Anne, MD CDER Disqualified 05/08/2008 05/18/2006 12/21/2007 PDF Text PDF Text
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
Palazzo, Maria Carmen, MD, PhD CDER Disqualified 03/01/2011 12/03/2003 PDF Text
Papilion, John D., MD CDER Disqualified 11/13/2014 04/11/2014 PDF
Patel, Manoj K., MD CDER Disqualified 05/23/2014 04/30/2014 PDF
Paulk, Jr., E Alan, MD CDER Disqualified 01/08/1990 05/06/1987 04/18/1988
Paull, Barry R., MD CDER Totally Restricted 11/12/1991
Perez, George, MD CDER Restrictions Removed 02/18/2000 10/05/1989
Phillips, Christopher M. CDER Disqualified 10/11/2006 01/20/2006 PDF Text
Pierce, Keith Jeffrey, MD CDER Disqualified 06/24/2010 03/17/2010 PDF Text
Poisson, Roger C., MD CDER Disqualified 05/28/1991
Quarles, Carey L., PhD CVM Disqualified 07/29/2002 08/14/1998
Rackley, Charles E., MD CDER Restrictions Removed 03/17/1986 08/26/1982
Ramirez-Melendez, Ramon, MD CDER Disqualified 11/21/2008 10/21/2008 PDF Text
Raper, Steven, MD CBER Restricted 02/10/2005
Raval, Pramod, MD CDER Restricted 08/25/2008 02/21/2008 Text
Razzaque, Naveed M.D. CDER Restricted 05/20/2021 06/04/2020 02/25/2021 PDF PDF
Reagan, Luther M., PhD CVM Disqualified 11/08/1991 07/01/1991
Redd, Burton L., MD CDRH Restricted 02/08/2005 03/11/2004 PDF Text
Reuben, Scott S., MD CDER Disqualified 04/05/2010 03/17/2010 PDF Text
Reynolds, Jr., James O., MD CDER Restrictions Removed 09/09/1989 04/07/1986
Riba, Arthur, MD CDER Restrictions Removed 11/29/2006 05/19/1999 02/17/1999 PDF PDF Text
Richards, Jon, MD CBER Restrictions Removed 05/12/2016 08/28/2012 PDF Text
Ritter, Arnold, DO CDER Disqualified 02/28/1980
Roberts, Kathleen E., MD CDER Disqualified 11/24/1964
Roberts, William S., MD CBER Disqualified 07/18/1991 05/14/1991
Robin, Bennett, MD CDER Disqualified 06/19/1964
Rosenthal, C J., MD CDER Disqualified 01/21/1998
Rossner, Stephen D., MD CDER Disqualified 02/21/2008 05/10/2006 PDF Text
Roth, Stanley F., MD CDER Disqualified 08/03/1982 05/07/1982
Rotstein, Jerome, MD CDER Disqualified 12/03/1975
Rowan, Noel M., MD CDER Disqualified 06/10/1985
Rubin, Wallace, MD CDER Disqualified 03/13/1970
Runels, Jr., Charles E., MD CBER Disqualified 08/06/2009 08/27/2008 02/13/2009 PDF Text PDF
Saadeh, Ghandi M., MD CDER Disqualified 07/27/2011 01/04/2010 11/17/2010 PDF Text PDF
Sams, Jr., W Mitchell, MD CDER Disqualified 10/23/1997
Sanguilly, Manuel, MD CDER Disqualified 11/23/1982 04/02/1982
Savery, Francois, MD CDER Disqualified 10/06/1978
Sawaya, Mary E., MD, PhD CDER Disqualified 05/19/2004
Scheiner, James J., MD CDER Disqualified 07/31/1979
Schneyer, Jerome J., MD CDER Disqualified 04/16/1978
Sherwin, Duane, MD CDER Disqualified 07/09/1982
Shirley, Sheridan W., MD CDER Totally Restricted 01/30/1984
Shroff, Phyllis F., MD CDER Totally Restricted 04/26/1983 07/31/1981
Shubin, Harry, MD CDER Disqualified 03/16/1970
Singleton, Charles M., MD CDER Not Disqualified 04/22/2008 04/02/1997 PDF Text
Slazinski, Leonard, MD CBER Disqualified 08/28/1991 05/14/1991
Smith, Lyman, MD CDER Reinstated 06/08/1983
Smith, Ronald C., MD CDER Disqualified 08/01/1979
Sobatka, Joseph H., MD CDER Disqualified 09/21/1970
Sparkuhl, Alexander, MD CDER Restricted 08/11/1999 07/01/1998 PDF
Spencer, Wayne E., MD CBER Disqualified 05/09/2011 04/20/2011 PDF Text
Spiers, Alexander S., MD CDER Reinstated 12/14/1990
Splitter, Samuel, MD CDER Disqualified 07/29/1968
Sriratana, Pramern, MD CDER Restricted 06/10/1988
Steele, Peter P., MD CDER Disqualified 04/02/1986
Steen, Stephen N., MD Burea Not Disqualified – Adequate Assurances1 09/05/1985
Stolman, Lewis P., MD CDER Adequate Assurances1 03/11/1991 11/16/1990
Straus, Marc J., MD CDER Disqualified 05/18/1982
Streb, Richard A., MD CDER Disqualified 01/03/1997
Summers, William K., MD CDER Restrictions Removed 07/24/2007 05/04/1989
Swanson, Todd V., MD CDRH Restricted 04/10/2005 05/05/2004 PDF Text
Taber, David O., MD CDER Totally Restricted 06/17/1982 09/26/1980 02/09/1981
Teplick, Steven K., MD CDER Disqualified 03/08/1994 04/12/1990 03/22/1991
Tewari, Anand, MD CBER Disqualified 11/18/1993 03/23/1995
Togias, Alkis, MD CDER Restrictions Removed 09/26/2006
Tonkon, Melvin, MD CDER Not Disqualified 03/30/1999 12/23/1998
Valdez, Mario P., MD CDER Totally Restricted 02/03/1994
Vestal, James C., MD CDER Disqualified 05/05/2008 05/09/2007 PDF Text
Villaman-Bencosme, Yvelice A., MD CDER Pending 01/18/2022 01/18/2022 09/26/2022 PDF PDF
Vriesendorp, Huibert M., MD, PhD CBER Disqualified 12/31/2001 11/19/1996 09/19/1997
Wallens, William T., MD CDER Disqualified 08/22/1983
Weiss, Jerome, MD CDER Disqualified 12/31/1984
Wholey, Mark H., MD CDRH Restricted 07/19/2006 10/21/2005 PDF Text
Williams, Joseph L., MD CDER Restrictions Removed (reinstated by correspondence) 05/15/2003 07/01/1998 PDF
Wilson, James M., MD, PhD CBER Restricted 02/09/2005 11/30/2000 02/08/2002 PDF PDF Text
Winchester, James F., MD CDER Restrictions Removed 05/24/1985 05/24/1982
Wong, David T., MD CDER Totally Restricted 07/09/1982 10/06/1980
Young, Robert E., MD CDER Disqualified 10/15/1982
Zabalgoitia-Reyes, Miguel, MD CDER Disqualified 07/02/2009 06/08/2009 PDF Text
Zackheim, Herschel S., MD CDER Restricted 08/23/1988 03/30/1988
Ziering, William H., MD CDER Disqualified 05/20/2008 11/06/1998 08/16/1999 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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