Restricted List
R= Clinical Investigators who have agreed
to some RESTRICTIONS
with respect to their conduct of clinical investigations.
RR= Restrictions Removed (see Comments for
date)
| Name Address |
Center |
Type |
Action Date |
Comments |
| ALBERT J BAZO, MD ALEXANDRIA,
VA |
CDER |
R |
04-NOV-1981 |
Only open studies allowed |
| RICHARD
R BRIGGS, MD LAS VEGAS NV |
CDRH |
R |
01-FEB-2005 |
By consent agreement. For 5 years: Among
other agreements, will notify FDA when he resumes clinical studies
and submit study protocol 30 days prior to study, personally supervise
staff, other investigators under his supervision; attend at least
2, acceptable to FDA, educational programs per year and arrange
for training and education of his research staff; provide annual
certification of compliance. |
JACQUES R. CALDWELL,
MD
GAINESVILLE, FL |
CDER |
R |
11-MAY-2006 |
By consent agreement, without admitting wrongdoing.
Among other agreements, for three (3) years if Dr. Caldwell decides
to conduct a clinical investigation will notify FDA CDER DSI of
his plans in writing; will not serve as PI for more than 2 such
investigations in the first year, not more than 3 in the second
year and no such limitation shall apply to the third year; and will
conduct clinical investigations only at clinical sites where he
directly performs work as a clinical investigator and can personally
supervise each investigation. |
ALFRED E. CHANG, MD
ANN ARBOR, MI |
CBER |
R |
09-Jan-2007 |
By consent agreement. May participate as a sub-investigator working under the supervision of a clinical investigator; external medical monitor must be engaged to oversee enrollment; no more than 20 subjects at one time; will provide yearly reports to FDA. Restriction will not be lifted until successfully performed as sub-investigator for 20 subjects.
(Previously served three year suspension imposed by his institution, then one year as a supervised subinvestigator.) |
THOMAS B EDWARDS, MD
ALBANY, NY |
------- |
R |
26-JAN-1998 |
By consent agreement perform no more
than 2 studies concurrently personally supervise study ensure qualifications
of assistants future studies evaluated by independent auditors every
6 months; DSI to be notified of any noncompliance; auditors' reports
must be made available to DSI upon request |
LOUIS F. FABRE, MD, PhD
HOUSTON, TX |
CDER |
R |
23-JUN-2008 |
By consent agreement. Restrictions for 3 years after
the date on which he resumes conducting clinical investigations
(e.g. first year no more than one clinical investigation, second
year no more than two clinical investigations, limited enrollment).
Provide FDA documentation of study involvement, training of
research staff prior to commencement of any clinical investigation, & annual
certification of compliance for 5 years from date of agreement. |
| JULIO M GARCIA, MD MIAMI,
FL |
CDER |
R |
19-OCT-1995 |
May participate in trials only as a sub-investigator
under the supervision of a principal investigator who assumes full
responsibility for study conduct |
| MARTHA H HAGAMAN,
MD HERMITAGE, TN |
CDER |
R |
09-JAN-2006 |
By consent agreement. Among other agreements, will
notify FDA in writing if she plans to conduct studies and will submit
study protocols to FDA thirty (30) days before the start of the
study. For a 3 year period following resumption of studies: Shall
not serve as clinical investigator for more than one (1) FDA regulated
clinical investigation in the first year she conducts studies, and
shall not serve as clinical investigator for more than two (2) FDA
regulated clinical investigations in the second year. During the
first and second years, she shall not be personally responsible
for more than fifteen (15) subjects enrolled in any given study.
In the third year, shall not serve as clinical investigator for
more than three (3) clinical investigations and shall not be personally
responsible for more than 25 subjects enrolled in any given study.
Shall not conduct or participate in any study as the sole investigator.
Dr. Hagaman will conduct studies only at clinical sites where she
directly performs work and therefore be physically present to personally
supervise the conduct of each clinical investigation. She will provide
FDA with documentation of the training provided to her research
staff and during the three (3) year period following the date she
resumes conducting clinical investigations she will provide annual
reports to FDA documenting the additional training. Prior to the
date she resumes conducting clinical investigations, Dr. Hagaman
will attend at least two (2) educational programs related to clinical
research and provide FDA with documentation of each program. |
ALAN F HOFMANN, MD
LA JOLLA, CA |
CDER |
R |
21-NOV-1995 |
May act as co-investigator or sub-investigator
with acceptable oversight |
| ROBERT E MORTON, MD ARLINGTON,
VA |
CDER |
R |
18-AUG-1988 |
Will not conduct more than one study
concurrently. Will be personally involved in specified aspects of
study conduct. |
| RICHARD E MUSTY, PHD BURLINGTON,
VT |
CDER |
R |
20-SEP-1990 |
May serve only as sub-investigator |
HOWARD
L. OFFENBERG, MD
ORMAND BEACH, FL |
CDER |
R |
28-NOV-2005 |
By consent agreement. Among other agreements: Will
notify FDA in writing if he plans to conduct studies. For 3 year
period following resumption of studies: Shall not serve as clinical
investigator for more than two (2) FDA regulated clinical investigations
in the first year he conducts studies, and shall not serve as clinical
investigator for more than three (3) FDA regulated clinical investigations
in the second year. In the third year, there will be no restriction
on the number of clinical investigations that he can serve as clinical
investigator. Dr. Offenberg will conduct studies only at clinical
sites where he directly performs work and therefore be physically
present to personally supervise the conduct of each clinical investigation.
He will provide FDA with documentation of the training provided
to his research staff and during the three (3) year period following
the date he resumes conducting clinical investigations he will provide
annual reports to FDA documenting the additional training. In the
two (2) year period following resumption of conducting studies Dr.
Offenberg will attend at least two (2) educational programs related
to clinical research and provide FDA with documentation of each
program. |
| CHARLES E RACKLEY, MD WASHINGTON,
DC |
CDER |
RR |
17-MAR-1983 |
(Restriction removed 17-MAR-1986) For
3 years: assure that co-workers assume full responsibility report
at 3-month intervals to the institutional review board |
| STEVEN
E RAPER, MD PHILADELPHIA, PA |
CBER |
R |
09-FEB-2005 |
By settlement agreement with Dept. of
Justice. Must complete clinical research educational programs; can
be investigator for one study at a time; external contract research
organization and external medical monitor must be engaged to oversee
conduct of the study. Restriction will not be lifted until 36 months
of supervised research is complete. Additional restrictions apply
to federally funded research. |
| PRAMOD RAVAL, MD Oak Park, MI |
CDER |
R |
25-AUG-2008 |
For 3 years from date on which he assumes role of clinical investigator: restriction to no more than two FDA regulated clinical trials; prohibition on clinical investigations involving scheduled drug substances; notification to FDA & supervision plan; clinical staff training; enrollment cap; proctor requirement; educational program; & certification of compliance. |
BURTON
L REDD, MD Visalia, CA
|
CDRH
|
R
|
04-FEB-2005
|
By consent agreement. For 5 years: Among
other agreements, will notify FDA when he resumes clinical studies
and submit study protocol 30 days prior to study, personally supervise
staff, other investigators under his supervision; attend at least
2, acceptable to FDA, educational programs per year and arrange
for training and education of his research staff; provide annual
certification of compliance.
|
ARTHUR RIBA,
MD
DEARBORN, MI
|
CDER |
See comments |
12-JAN-2004 |
By consent agreement has implemented,
prior to 12-JAN-2004, additional policies/procedures re staff hiring,
training, supervision |
ALEXANDER SPARKUHL
LAS VEGAS, NV |
CDER |
R |
11-AUG-1999 |
By consent agreement. For 3 years, will
not be an investigator using investigational new drugs. |
PRAMERN SRIRATANA, MD
NORMAL, IL |
CDER |
R |
10-JUN-1988 |
Will not conduct studies with investigational
drugs other than "Group C" cancer drugs. |
TODD
V SWANSON, MD
LAS VEGAS, NV |
CDRH |
R |
15-APR-2005 |
By consent agreement, for five (5) years: study
oversight by Division of Bioresearch Monitoring (DBM) with the following
restrictions: to notify and provide DBM a copy of a study protocol
prior to initiating a study; submission of a plan that describes
how he will personally supervise staff, including sub-investigators,
and standard operating procedures that he will institute to ensure
adequate oversight of his research staff; attend, on an annual basis,
at least two (2) educational programs acceptable to FDA and provide
documentation of completion; arrange training and education of his
research staff, including sub-investigators; and certify in writing,
on an annual basis that he is in compliance with the terms of the
agreement. |
MARK S.
WHOLEY, M.D.
Pittsburg, PA |
CDRH |
R |
17-JUL-2006 |
By consent agreement, without admitting wrongdoing.
Agrees to cease current premarket clinical studies. If Dr. Wholey
decides to participate in future premarket clinical studies, Dr.
Wholey agrees to conditions for a period of three years thereafter
that include: not serving as principal clinical investigator in
any premarket studies; serving as a clinical investigator for no
more than three (3) premarket investigations at any time, under
the supervision of a principal clinical investigator; enrolling
no more than 20 subjects in total in all of his ongoing premarket
clinical studies at any time, unless an exception is granted by
FDA; submitting protocol, SOPs, and supervision plan to FDA 30 days
prior to beginning study; completing educational requirements consisting
of one (1) course within 6 months prior to submission to FDA of
first premarket study protocol and 3 courses per year for following
three years; and annually certifying compliance. Agreement does
not restrict Dr. Wholey's participation in postmarket clinical studies
of labeled uses of cleared or approved products. |
| JAMES
M WILSON, MD, PhD PHILADELPHIA, PA |
CBER |
R |
09-FEB-2005 |
By settlement agreement with Dept. of
Justice. Cannot serve as a sponsor for five years. Must complete
clinical research educational programs; can be investigator for
one study at a time; external contract research organization and
external medical monitor must be engaged to oversee conduct of the
study. Restriction will not be lifted until 36 months of supervised
research is complete, and will not be lifted for at least five years.
Must author a "lessons learned" article. Additional restrictions
apply to federally funded research. |
HERSCHEL S ZACKHEIM, MD
SAN FRANCISCO, CA |
CDER |
R |
24-AUG-1988 |
will be limited to study no more than
20 patients at a time will work under a proctor |
| list formatted 11/21/2001(tc)n=37;
1/15/2002(tc)n=23;
list revised 06/27/2002 (tc)n=24; 10/16/2001(tc)n=25;
list revised 09/10/2003(tc)n=27
list revised 02/23/2004(tc)n=28
list corrected 04/09/2004(tc)n=28
list updated 05/12/2004(tc)n=28
list revised 02/01/2005(tc)n=29
list revised 03/08/2005(tc)n=31; corrected 03/14/2005
list revised 04/11/2005(tc)n=34
list revised 05/17/2005(tc)n=35
list revised 05/20/2005(tc)n=36
list revised 12/14/2005(tf)n=37
list revised 03/08/2006(tf)n=38
list revised 05/23/2006(tf)n=39
list revised 07/17/2006(ca)n=40
list revised 09/25/2006(ca)n=41
list revised 10/19/2006(ca)n=42
list revised 01/23/2007(ca)n=43 |
