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U.S. Department of Health and Human Services

Clinical Investigators - Disqualification Proceedings

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Location: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=clinicalinvestigatorsdisqualificationproceedings

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Clinical Investigators - Disqualification Proceedings


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   No. of Records Found:  229
Name Center Status Date of status Date NIDPOE Issued Date NOOH Issued Link to NIDPOE Letter Link to NOOH Letter
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

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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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