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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
Gatenby, Robert A., MD CDER Reinstated pursuant to Agreement 02/16/2023 09/25/1988
Villaman-Bencosme, Yvelice A., MD CDER Pending 01/18/2022 01/18/2022 09/26/2022 PDF PDF
Razzaque, Naveed M.D. CDER Restricted 05/20/2021 06/04/2020 02/25/2021 PDF PDF
Arata, MD, Michael A. CDRH Disqualified 05/21/2018 09/13/2016 06/21/2017 PDF Text
Baker, James, MD CDER Disqualified 05/01/2018 03/23/2018 PDF
Lichty, Charles P., MD CDER Disqualified 12/23/2016
Richards, Jon, MD CBER Restrictions Removed 05/12/2016 08/28/2012 PDF Text
Calenoff, Emanuel, MD CDER Disqualified 12/18/2015 09/25/2014 04/10/2015 PDF PDF
Bilezikian, John P., MD CDER Not Disqualified 11/27/2015 01/12/2015
Marquez, Farid, MD CDER Disqualified 08/06/2015 06/26/2015 PDF
Papilion, John D., MD CDER Disqualified 11/13/2014 04/11/2014 PDF
Berger, Daniel S., MD CDER Restrictions Removed 09/10/2014 11/27/2009 PDF
Corbett III, Bernard A., MD CDER Disqualified 08/07/2014 07/16/2014 PDF
Niederman, Alan, MD CBER Restrictions Removed 07/25/2014 11/01/2010 PDF Text
Berger, Michael Dean, MD CBER Disqualified 06/20/2014 09/26/2011 12/18/2012 PDF PDF
Patel, Manoj K., MD CDER Disqualified 05/23/2014 04/30/2014 PDF
Mendolia, Thomas Francis, DO CDER Disqualified 01/14/2014 11/22/2011 03/18/2013 PDF Text Text
Alexander, Elmore, DO CDER Disqualified 08/15/2013 01/27/2012 08/15/2012
Lasala, Gabriel Perez, MD CBER Restricted 07/16/2013 02/16/2012 PDF Text
Candal, Francisco J., MD CDER Disqualified 03/29/2012 03/02/2011 09/29/2011 PDF Text
Saadeh, Ghandi M., MD CDER Disqualified 07/27/2011 01/04/2010 11/17/2010 PDF Text PDF
Spencer, Wayne E., MD CBER Disqualified 05/09/2011 04/20/2011 PDF Text
Palazzo, Maria Carmen, MD, PhD CDER Disqualified 03/01/2011 12/03/2003 PDF Text
Holmes, Amy S., MD CDER Disqualified 01/11/2011 12/02/2010 PDF Text
Macapinlac, Manuel, MD CDER Disqualified 08/26/2010 02/23/2009 04/19/2010 PDF Text PDF Text
Loucks, David Craig, MD CDER Restricted 08/16/2010 08/18/2009 PDF Text
Lu, Eugene, MD CDER Restricted 07/08/2010 03/16/2010 PDF Text
Pierce, Keith Jeffrey, MD CDER Disqualified 06/24/2010 03/17/2010 PDF Text
Chang, Alfred E., MD CBER Disqualified 04/07/2010 11/06/2002 10/09/2003 PDF Text PDF Text
Reuben, Scott S., MD CDER Disqualified 04/05/2010 03/17/2010 PDF Text
Hendrick, Kim C., MD CDER Disqualified 12/11/2009 05/11/2006 07/01/2009 PDF Text
Marker, Howard W., MD CDER Disqualified 10/08/2009 01/29/2009 PDF Text
Runels, Jr., Charles E., MD CBER Disqualified 08/06/2009 08/27/2008 02/13/2009 PDF Text PDF
Davidson, Jeffrey N., DVM CVM Disqualified 07/20/2009 11/07/1997
Zabalgoitia-Reyes, Miguel, MD CDER Disqualified 07/02/2009 06/08/2009 PDF Text
Gupta, Suresh, MD CDER Not Disqualified 06/29/2009 09/12/2008 PDF Text
Ericsson, Arthur Dale, MD CDER Disqualified 05/04/2009 03/31/2008 03/04/2009 PDF Text PDF Text
McGee, J Michael, MD CBER Disqualified 01/08/2009 06/21/2001 05/21/2002 PDF PDF Text
Ramirez-Melendez, Ramon, MD CDER Disqualified 11/21/2008 10/21/2008 PDF Text
Garjian, Peggy Ann, MD CDER Disqualified 09/22/2008 08/25/2008 PDF Text
Holland, James A., MD CDER Disqualified 08/25/2008 09/22/2004 08/14/2007 PDF Text
Raval, Pramod, MD CDER Restricted 08/25/2008 02/21/2008 Text
Guy, Matthew J., MD CDER Disqualified 07/25/2008 01/24/2008 PDF Text
Fabre, Louis F., MD, PhD CDER Restricted 06/23/2008 01/19/2005 PDF Text
Gentry, Layne O., MD CDER Disqualified 06/18/2008 03/23/1998 04/15/1999 PDF PDF Text
Ziering, William H., MD CDER Disqualified 05/20/2008 11/06/1998 08/16/1999 PDF PDF Text
Kirkman Campbell, Maria Anne, MD CDER Disqualified 05/08/2008 05/18/2006 12/21/2007 PDF Text PDF Text
Vestal, James C., MD CDER Disqualified 05/05/2008 05/09/2007 PDF Text
Lofgren, David Nils, MD CBER Disqualified 04/28/2008 11/09/2007 PDF Text
Achreja, Manjeet Kaur, MD CDER Disqualified 04/24/2008 08/29/2007 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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