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Updated: 2007-04-18

RESTRICTIONS REMOVED LIST FOR CLINICAL INVESTIGATORS

FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and, in the case of research involving human subjects, to help protect the rights, safety, and welfare of those subjects.

The following list contains the names of all clinical investigators who previously agreed to certain restrictions with respect to their conduct of clinical investigations. The decision to offer a restricted agreement is within the discretion of FDA. Under the terms of the agreements with the following clinical investigators, the restrictions in their agreements no longer apply and are removed. Clinical investigators on this list are again eligible to receive investigational products in accordance with all applicable regulatory requirements.

FDA maintains separate lists for clinical investigators who have been disqualified (or totally restricted) from receiving investigational products; clinical investigators who have agreed to certain restrictions with respect to their conduct of clinical investigations; and clinical investigators who, under regulations in effect until 1987, provided adequate assurances with respect to their future compliance with requirements applicable to the use of investigational drugs and biologics (http://www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm). These lists are updated regularly.

For further information about these lists, contact the program coordinator.

FDA also makes available a separate list of firms or persons debarred pursuant to the debarment provisions of the Federal Food, Drug, and Cosmetic Act (http://www.fda.gov/ora/compliance_ref/debar/default.htm).

In addition, the DHHS, Public Health Service, Office of Research Integrity, Administrative Actions Listing is located at: http://silk.nih.gov/public/cbz1bje.@www.orilist.html

(Website created 09-25-06)
Updated: 10/19/2006 Added: Togias, Alkis
Updated: 08/01/2007 Added: Walter N. Gaman, M.D.
Updated: 08/30/2007 Added: William K. Summers, M.D.
Updated: 10/10/2007 Added: Mark L. Batshaw, M.D.
Updated 1/4/2008: Added Gary A. Cohen, M.D.
Updated 4/18/2008: Added Emad Dean Nukta, M.D.
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 investigations…of an investigation article at any one time…"
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