Restricted Removed 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 |
NAYAB ALI, MD WASHINGTON,
DC |
CDER |
RR |
23-JUN-1982 |
(Restriction removed 23-JUN-1986) For
4 years: work under a proctor submit studies for prior approval
to the Division of Scientific Investigations, Office of Compliance,
FDA. be personally involved in specified aspects of study conduct
other restrictions as specified |
RICHARD
M ALLMAN, MD BIRMINGHAM, AL |
CDER |
RR |
01-SEP-1999 |
(Restriction removed 01-SEP-2002)
By consent agreement. Can be PI for no more than 2 studies at a
time; each study can have no more than 25 subjects; must attend
educational programs in the area of clinical research studies; must
be proctored by a licensed physician experienced in clinical trial
research. |
MARK L BATSHAW, MD WASHINGTON, DC |
CBER |
RR |
09-FEB-2005 |
(Restriction removed 1-OCT-2007) By settlement agreement with Dept. of Justice. Restricted for three years; must complete clinical research educational programs; medical monitor retained; third party to oversee regulatory compliance of clinical research; annually, for three years, must provide certification of compliance to FDA and NIH. |
BRIAN BROWNE, MD BALTIMORE,
MD |
CDER |
RR |
23-DEC-1992 |
(Restriction removed: 23-DEC-1997) For
5 years: will not conduct a study as sole principal investigator
must secure study approval from specified University of MD officials
|
GARY A COHEN, MD SAN DIEGO, CA |
CDER |
RR |
14-JAN-2005 |
(Restriction removed 4-JAN-2008) By consent agreement. For 3 years: Shall not serve as clinical investigator for more than two (2) FDA regulated clinical investigations of an investigational article in the first year, and shall not serve as clinical investigator for more than three (3) FDA regulated clinical investigations...in second and third years...shall not enroll more than 25 subjects per study. He must notify FDA of his plans for two ongoing studies. He has agreed to attend 2 educational programs per year and arrange for training and education, and provide personal supervision of his research staff. |
DAVID
P. FAXON, MD LOS ANGELES, CA |
CDER |
RR |
19-JUN-2002 |
(Restriction removed 19-JUN-2005) By
consent agreement. For 3 years: Shall not be principal investigator
for more than two (2) FDA regulated clinical investigations
at any one time (with additional provisions); shall not be principal
clinical investigator for study that enrolls more than 25 subjects
at the site where he is the principal investigator; and additional
provisions. |
FRANK A FINNERTY JR, MD WASHINGTON,
DC |
CDER |
RR |
04-DEC-1985 |
(Restriction removed 04-DEC-1988) For
3 years: perform no more than 2 studies concurrently provide written
instructions for all employees working in the study personally and
regularly see all study subjects; obtain all consents; review all
raw data and case report forms |
WALTER N GAMAN, MD IRVING,
TX |
CDER |
RR |
31-JUL-2003 |
(Restriction removed 31-JUL-2006) For 3 years; restrictions in part, as principal clinical investigator for no more than 2 "FDA regulated clinical investigationsā¦of an investigation article at any one timeā¦" |
HENRY W JOLLY JR, MD NEW
ORLEANS, LA |
CDER |
RR |
17-NOV-1983 |
(Restriction removed 17-NOV-1986) For
3 years: assure that coworkers assume full responsibility report
at 3-month intervals to the institutional review board personally
see subjects in studies he conducts |
LOIS
ANNE KATZ, MD NEW YORK, NY |
CDER |
RR |
23-AUG-2002 |
(Restriction removed 21-AUG-2005) For
3 years: Shall not be principal investigator for more than one additional
study clinical investigation at any one time; attend at least 2
educational programs on clinical research studies; arrange training
and education of staff in conduct of clinical trials; provide annual
certification of compliance |
MARTIN LEVITT, MD WINNIPEG
MB, NG |
CDER |
RR |
02-MAY-1986 |
(Restriction removed 02-MAY-1989) For
3 years: personally see all subjects for whom he is responsible
assure that coworkers assume full responsibility |
CHARLES A LINKER, MD SAN
FRANCISCO, CA |
CDER |
RR |
31-MAR-1988 |
(Restriction removed 18-MAY-1989) Until
5/18/89: will not be a principal investigator and will be supervised
on studies in which he participates by another physician |
ABRAHAM MITTELMAN, MD VALHALLA,
NY |
CBER |
RR |
09-JUN-1995 |
(Restriction removed 09-DEC-1995) Total
restriction for 6 months. After 09-Dec-95 for 3 years: may participate
in no more than 3 studies concomitantly; no more than 20 subjects
at a time; will not be sole principal investigator; will provide
quarterly reports to FDA. |
JOHN S
NAJARIAN, MD MINNEAPOLIS, MN |
CBER |
RR |
19-JAN-1994 |
(Restrictions removed: 17-NOV-1998)
Total restriction pending outcome of ongoing federal investigations. |
EMAD DEAN NUKTA, MD CLEVELAND, OH |
CDRH |
RR |
10-APR-2005 |
(Restriction removed 26-MAR-2008) By consent agreement. For 3 years: Among other agreements, ceases to enroll additional subjects under ongoing protocols and not serve as clinical investigator under additional protocols without FDA approval of his educational programs, plans for providing study oversight, and proposed protocols; will attend at least 2, acceptable to FDA, educational programs per year; arrange for training and education of his research staff within 90 days; and provide annual certification of compliance |
GEORGE PEREZ, MD NEWARK,
NJ |
CDER |
RR |
11-DEC-1989 |
(Restriction removed 18-FEB-2000) Will
no longer be eligible to receive or conduct future studies with
ozonated blood in patients infected with HIV or other disease conditions
|
JAMES O REYNOLDS JR, MD
COLUMBIA, MO |
CDER |
RR |
09-SEP-1986 |
(Reinstated 09-SEP-1989) For 3 years:
personally see all subjects work under a proctor |
WILLIAM K SUMMERS, MD
ARCADIA, CA |
CDER |
RR |
04-MAY-1989 |
(Restriction removed 24-JUL-2007) Direct personal involvement in specific aspects of study conduct and reporting |
ALKIS TOGIAS, MD
BALTIMORE, MD |
CDER |
RR |
02-JUN-2003 |
(Restrictions removed 26-SEP-2006) For 3 years; restrictions
in part, "...will not serve as principal clinical investigator
for more than one FDA regulated clinical study per year..." |
JAMES F WINCHESTER, MD WASHINGTON,
DC |
CDER |
RR |
24-MAY-1982 |
(Restriction removed 24-MAY-1985) For
3 years: work under a proctor submit studies for prior approval
to the Division of Scientific Investigations, Office of Compliance,
FDA. be personally involved in specified aspects of study conduct.
|
list formatted 09/25/2006(ca)n=1
List Updated 10/19/06 (ca) n=2
|