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Clinical Investigators - Disqualification Proceedings
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Name Center Status Date of status Date NIDPOE Issued Date NOOH Issued Link to NIDPOE Letter Link to NOOH Letter 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
Valdes, Martin, MD
CDER
Pending
07/15/2024
07/15/2024
PDF
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
Disqualified
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.