ADEQUATE ASSURANCES 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, for
investigations involving human subjects, to help protect the rights, safety, and
welfare of these subjects.
The following list contains the names of all clinical investigators who have
provided FDA with adequate assurances of their future compliance with
requirements applicable to the use of investigational drugs and biologics. Under
regulations in effect until 1987, clinical 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.
Clinical investigators can no longer provide "adequate assurances" to avoid
disqualification. The final rule entitled "New Drug, Antibiotic, and Biologic
Drug Product Regulations," deleted the provision allowing clinical investigators
to avoid disqualification through the submission of adequate assurances of
future compliance. See 52 Fed. Reg. 8798, at 8826 (March 19, 1987). The
disqualification regulation for devices (21 CFR 812.119) never provided for the
submission of adequate assurances as a means of avoiding disqualification.
FDA maintains separate lists of clinical investigators who have been
disqualified (or totally restricted) from receiving investigational products:
and clinical investigators who have agreed to certain restrictions with respect
to their conduct of clinical studies (http://www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm),
and clinical investigators who agreed to certain restrictions which have now
been removed.
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://ori.hhs.gov/misconduct/AdminBulletinBoard.shtml
List updated: 06/02/2000 (Edited 6/29/06)
ADEQUATE ASSURANCES List
A = Clinical investigators who have provided ADEQUATE ASSURANCES with
respect to their future compliance.
List Accessed: 11/21/01
Name Address |
Center |
Type |
Action Date |
Comments |
CAL K COHN, MD
HOUSTON, TX |
CDER |
A |
17-APR-1991 |
Through consent agreement will conduct future studies in
accordance with standard operating procedures which shall include:
- third party verification of study subjects' ID
- obtaining information on prior medical treatments
- correcting errors in study records, clearly dating and initialing changes.
|
MICHAEL C GELFAND, MD
WASHINGTON, DC |
CDER |
A |
18-OCT-1981 |
Assurances were accepted after a regulatory hearing. No
specific conditions, |
JOHN H HOPKINSON III, MD
ABINGTON, PA |
CDER |
A |
03-JUN-1983 |
After a regulatory hearing;
- will notify all future sponsors of assurances and past regulatory proceedings
- single dose studies only
|
DONALD F KLEIN, MD
NEW YORK, NY |
CDER |
A |
03-MAR-1986 |
By consent agreement
- all lab reports, tests, and concomitant medication will be accurately reported in case
report forms
- all changes in testing procedures will be clearly identified in the protocol and to the
institutional review board
- if Dr. Klein does not complete case report forms himself, trained personnel will be
employed to maintain
|
MAURICE LIPPMANN, MD
TORRANCE, CA |
CDER |
A |
05-NOV-1984 |
After a regulatory hearing;
personally admit, obtain consent, and administer drug to at least 50% of subjects in
studies. |
MARTIN S MOK, MD
TORRANCE, CA |
CDER |
A |
23-MAR-1983 |
After a regulatory hearing;
increase direct involvement in studies. |
STEPHEN N STEEN, MD
TORRANCE, CA |
CDER |
A |
05-SEP-1985 |
After a regulatory hearing;
direct personal involvement with at least 50% of study subjects. |
LEWIS P STOLMAN, MD
MAPLEWOOD, NJ |
CDER |
A |
11-MAR-1991 |
By consent agreement;
will not conduct future studies with Aetoxisclerol. |
Page Reformatted: November 21, 2001
(tc) |