Inspections, Compliance, Enforcement, and Criminal Investigations
All clinical investigators who, under regulations in effect until 1987, have provided FDA with adequate assurances of their future compliance with requirements applicable to the use of investigational drugs and biologics.
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
|CDER||A||17-APR-1991||Through consent agreement will conduct future studies in accordance with standard operating procedures which shall include:
|MICHAEL C GELFAND, MD
|CDER||A||18-OCT-1981||Assurances were accepted after a regulatory hearing. No specific conditions,|
|JOHN H HOPKINSON III, MD
|CDER||A||03-JUN-1983||After a regulatory hearing;
|DONALD F KLEIN, MD
NEW YORK, NY
|CDER||A||03-MAR-1986||By consent agreement
|MAURICE LIPPMANN, MD
|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
|CDER||A||23-MAR-1983||After a regulatory hearing;
increase direct involvement in studies.
|STEPHEN N STEEN, MD
|CDER||A||05-SEP-1985||After a regulatory hearing;
direct personal involvement with at least 50% of study subjects.
|LEWIS P STOLMAN, MD
|CDER||A||11-MAR-1991||By consent agreement;
will not conduct future studies with Aetoxisclerol.
Page Reformatted: November 21, 2001 (tc)