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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 |
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Gupta, Suresh, M.D. | 9/12/08 |
Center for Drug Evaluation and Research | PDF HTML |
Ramirez Melendez, Ramon M.D. | 8/28/2008 |
Center for Drug Evaluation and Research | PDF HTML |
Ericsson, Arthur, M.D. | 3/31/08 |
Center for Drug Evaluation and Research | PDF HTML |
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 | |
Lofgren, David N., M.D. | 11/9/07 |
Center for Biologics Evaluation and Research | |
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 HTML |
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 HTML |
Hendrick, Kim C., M.D. | 5/11/06 |
Center for Drug Evaluation and Research | PDF HTML |
Rossner, Stephen D., M.D. | 5/10/06 |
Center for Drug Evaluation and Research | PDF HTML |
Phillips, Christopher M., M.D. | 1/20/06 |
Center for Drug Evaluation and Research | PDF HTML |
Wholey, Mark S., M.D. | 10/21/05 |
Center for Devices and Radiological Health | PDF HTML |
McLeod, Jeffrey L., M.D. |
8/24/05 |
Center for Drug Evaluation and Research | PDF HTML |
Hagaman, Martha H., M.D. |
3/1/05 |
Center for Drug Evaluation and Research | PDF HTML |
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 HTML |
Holland, James A., M.D. |
9/22/04 |
Center for Drug Evaluation and Research | PDF HTML |
Cohen, Gary A., M.D. |
8/17/04 |
Center for Drug Evaluation and Research | PDF HTML |
Caldwell, Jacques R., M.D. |
6/10/04 |
Center for Drug Evaluation and Research | PDF HTML |
Offenberg, Howard L., M.D. |
6/8/04 |
Center for Drug Evaluation and Research | PDF HTML |
Swanson, Todd V., M.D. |
5/5/04 |
Center for Devices and Radiological Health | PDF HTML |
Marcus, Eugenia, M.D. |
4/22/04 |
Center for Biologics Evaluation and Research | PDF HTML |
Redd, Burton L., M.D. |
3/11/04 |
Center for Devices and Radiological Health | PDF HTML |
Briggs, Richard R., M.D. |
3/9/04 |
Center for Devices and Radiological Health | PDF HTML |
Palazzo, Maria Carmen, M.D., Ph.D. |
12/3/03 |
Center for Drug Evaluation and Research | PDF HTML |
Daley, Patrick J., M.D. |
6/23/03 |
Center for Biologics Evaluation and Research | PDF HTML |
Chang, Alfred E., M.D. |
11/6/02 |
Center for Biologics Evaluation and Research | PDF HTML |
Gaman, Walter N., M.D. |
10/23/02 |
Center for Dug Evaluation and Research | PDF HTML |
Norman, Allyn M., D.O. |
|
Center for Drug Evaluation and Research | PDF HTML |
Mathew, Chavaramplakil P., M.D. |
|
Center for Drug Evaluation and Research | PDF HTML |
McGee, J. Michael, M.D. |
|
Center for Biologics Evaluation and Research | View File |
LaHaye, Leon C., M.D. |
|
Center for Devices and Radiological Health | View File |
DeAbate, Carl Andrew, M.D. |
|
Center for Drug Evaluation and Research | View File |
Wilson, James M., M.D., Ph.D. |
|
Center for Biologics Evaluation and Research | View File |
Anderson, Roger D., M.D. |
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Center for Drug Evaluation and Research | View File |
Katz, Lois A., M.D. |
|
Center for Drug Evaluation and Research | View File |
Law, Peter K., Ph.D. |
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Center for Biologics Evaluation and Research | View File |
Faxon, David P., M.D. |
|
Center for Drug Evaluation and Research | View File |
Page, Roy C., M.D. |
|
Center for Biologics Evaluation and Research | View File |
Riba, Arthur, M.D. |
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Center for Drug Evaluation and Research | View File |
Ziering, William H., M.D. |
|
Center for Drug Evaluation and Research | View File |
Acevedo, Eduardo Caro, M.D. |
|
Center for Drug Evaluation and Research | View File |
Allman, Richard M., M.D. |
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Center for Drug Evaluation and Research | View File |
Sparkuhl, Alexander, M.D. |
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Center for Drug Evaluation and Research | View File |
Williams, Joseph L., M.D. |
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Center for Drug Evaluation and Research | View File |
Gentry, Layne O., M.D. |
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Center for Drug Evaluation and Research | View File |