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FDA's Electronic
Freedom of Information
Reading Room
Notice of Initiation of Disqualification Proceedings and
Opportunity to Explain (NIDPOE) Letters

Copies of Notice of Initiation of Disqualification Proceedings and Opportunity to Explain Letter(s) (NIDPOE letter) may be accessed below. A NIDPOE letter informs the recipient clinical investigator that FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to the Food and Drug Administration's regulations. Generally, FDA issues a NIDPOE letter when it believes it has evidence that the clinical investigator repeatedly or deliberately violated FDA's regulations governing the proper conduct of clinical studies involving investigational products or submitted false information to the sponsor.

FDA also maintains lists clinical investigators who have been restricted or disqualified (i.e., "totally restricted"), who have had their restrictions removed, and who have provided adequate assurance of future compliance http://www.fda.gov/ora/compliance_ref/bimo/dis_res_assur.htm. If you wish to obtain available additional information from the Agency regarding a particular NIDPOE Letter, inquiries should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at http://www.fda.gov/opacom/backgrounders/foiahand.html.

The NIDPOE Letters are in PDF format. PDF Readers are available for free from the Adobe Acrobat web site.

Name Date Issued Issuing Office File
Gupta, Suresh, M.D.
9/12/08
Center for Drug Evaluation and Research PDF
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Ramirez Melendez, Ramon M.D.
8/28/2008
Center for Drug Evaluation and Research PDF
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Ericsson, Arthur, M.D.
3/31/08
Center for Drug Evaluation and Research PDF
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Raval, Pramod, M.D.
2/21/08
Center for Drug Evaluation and Research PDF
HTML
Guy, Matthew, M.D.
1/24/08
Center for Drug Evaluation and Research

PDF
HTML

Lofgren, David N., M.D.
11/9/07
Center for Biologics Evaluation and Research

PDF
HTML

Agus, Bertrand, M.D.
9/27/07
Center for Drug Evaluation and Research PDF
HTML
Achreja, Manject Kaur, M.D.
8/29/07
Center for Drug Evaluation and Research PDF
HTML
Overlie, Paul A. M.D.
7/31/07
Center for Devices and Radiological Health PDF
HTML
Vestal, James, M.D.
5/9/07
Center for Drug Evaluation and Research PDF
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Bigg, Daniel, M.D.
1/24/07
Center for Biologics Evaluation and Research PDF
HTML
Campbell, Anne K., M.D.
5/18/06
Center for Drug Evaluation and Research PDF
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Hendrick, Kim C., M.D.
5/11/06
Center for Drug Evaluation and Research PDF
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Rossner, Stephen D., M.D.
5/10/06
Center for Drug Evaluation and Research PDF
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Phillips, Christopher M., M.D.
1/20/06
Center for Drug Evaluation and Research PDF
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Wholey, Mark S., M.D.
10/21/05
Center for Devices and Radiological Health PDF
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McLeod, Jeffrey L., M.D.
8/24/05
Center for Drug Evaluation and Research PDF
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Hagaman, Martha H., M.D.
3/1/05
Center for Drug Evaluation and Research PDF
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Fabre, Louis F., M.D., Ph.D.
1/19/05
Center for Drug Evaluation and Research PDF
HTML
Nukta, Emad D., M.D.
9/30/04
Center for Devices and Radiological Health PDF
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Holland, James A., M.D.
9/22/04
Center for Drug Evaluation and Research PDF
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Cohen, Gary A., M.D.
8/17/04
Center for Drug Evaluation and Research PDF
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Caldwell, Jacques R., M.D.
6/10/04
Center for Drug Evaluation and Research PDF
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Offenberg, Howard L., M.D.
6/8/04
Center for Drug Evaluation and Research PDF
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Swanson, Todd V., M.D.
5/5/04
Center for Devices and Radiological Health PDF
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Marcus, Eugenia, M.D.
4/22/04
Center for Biologics Evaluation and Research PDF
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Redd, Burton L., M.D.
3/11/04
Center for Devices and Radiological Health PDF
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Briggs, Richard R., M.D.
3/9/04
Center for Devices and Radiological Health PDF
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Palazzo, Maria Carmen, M.D., Ph.D.
12/3/03
Center for Drug Evaluation and Research PDF
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Daley, Patrick J., M.D.
6/23/03
Center for Biologics Evaluation and Research PDF
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Chang, Alfred E., M.D.
11/6/02
Center for Biologics Evaluation and Research PDF
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Gaman, Walter N., M.D.
10/23/02
Center for Dug Evaluation and Research PDF
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Norman, Allyn M., D.O.
06/27/02
Center for Drug Evaluation and Research PDF
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Mathew, Chavaramplakil P., M.D.
06/27/01
Center for Drug Evaluation and Research PDF
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McGee, J. Michael, M.D.
06/21/01
Center for Biologics Evaluation and Research View File
LaHaye, Leon C., M.D.
05/11/01
Center for Devices and Radiological Health View File
DeAbate, Carl Andrew, M.D.
04/13/01
Center for Drug Evaluation and Research View File
Wilson, James M., M.D., Ph.D.
11/30/00
Center for Biologics Evaluation and Research View File
Anderson, Roger D., M.D.
9/13/00
Center for Drug Evaluation and Research View File
Katz, Lois A., M.D.
8/21/00
Center for Drug Evaluation and Research View File
Law, Peter K., Ph.D.
6/30/00
Center for Biologics Evaluation and Research View File
Faxon, David P., M.D.
4/7/00
Center for Drug Evaluation and Research View File
Page, Roy C., M.D.
4/6/00
Center for Biologics Evaluation and Research View File
Riba, Arthur, M.D.
5/19/99
Center for Drug Evaluation and Research View File
Ziering, William H., M.D.
11/6/98
Center for Drug Evaluation and Research View File
Acevedo, Eduardo Caro, M.D.
8/28/98
Center for Drug Evaluation and Research View File
Allman, Richard M., M.D.
7/10/98
Center for Drug Evaluation and Research View File
Sparkuhl, Alexander, M.D.
7/1/98
Center for Drug Evaluation and Research View File
Williams, Joseph L., M.D.
7/1/98
Center for Drug Evaluation and Research View File
Gentry, Layne O., M.D.
3/23/98
Center for Drug Evaluation and Research View File

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FDA/Freedom of Information