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/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm

 

Name	Date Issued	Issuing Office
Acevedo, Eduardo Caro, M.D.(PDF - 923KB) Text Version	08/28/1998	Center for Drug Evaluation and Research
Achreja, Manject Kaur, M.D. (PDF - 393KB) Text Version	08/29/2007	Center for Drug Evaluation and Research
Agus, Bertrand, M.D. (PDF - 513KB) Text Version	09/27/2007	Center for Drug Evaluation and Research
Allman, Richard M., M.D. (PDF - 354KB)	07/10/1998	Center for Drug Evaluation and Research
Anderson, Roger D., M.D. (PDF - 268KB)	09/13/2000	Center for Drug Evaluation and Research
Bigg, Daniel, M.D. (PDF - 1,140KB) Text Version	01/24/2007	Center for Biologics Evaluation and Research
Briggs, Richard R., M.D. (PDF - 499KB) Text Version	03/09/2004	Center for Devices and Radiological Health
Caldwell, Jacques R., M.D. (PDF - 765KB) Text Version	06/10/2004	Center for Drug Evaluation and Research
Campbell, Anne K., M.D. (PDF - 199KB) Text Version	05/18/2006	Center for Drug Evaluation and Research
Chang, Alfred E., M.D. (PDF - 1,104KB) Text Version	11/06/2002	Center for Biologics Evaluation and Research
Cohen, Gary A., M.D. (PDF - 627KB) Text Version	08/17/2004	Center for Drug Evaluation and Research
Daley, Patrick J., M.D.(PDF - 1,042KB) Text Version	06/23/2003	Center for Biologics Evaluation and Research
DeAbate, Carl Andrew, M.D. (PDF - 473KB)	04/13/2001	Center for Drug Evaluation and Research
Ericsson, Arthur, M.D. (PDF - 532KB) Text Version	03/31/2008	Center for Drug Evaluation and Research
Fabre, Louis F., M.D., Ph.D. (PDF - 854KB) Text Version	01/19/2005	Center for Drug Evaluation and Research
Faxon, David P., M.D. (PDF - 386KB)	04/07/2000	Center for Drug Evaluation and Research
Gaman, Walter N., M.D. (PDF - 432KB) Text Version	10/23/2002	Center for Dug Evaluation and Research
Garjian, Peggy Ann, M.D. (PDF - 485KB) Text Version	08/25/2008	Center for Drug Evaluation and Research
Gentry, Layne O., M.D. (PDF - 333KB)	03/23/1998	Center for Drug Evaluation and Research
Gupta, Suresh, M.D. (PDF - 411KB) Text Version	09/12/2008	Center for Drug Evaluation and Research
Guy, Matthew, M.D. (PDF - 587KB) Text Version	01/24/2008	Center for Drug Evaluation and Research
Hagaman, Martha H., M.D. (PDF - 729KB) Text Version	03/01/2005	Center for Drug Evaluation and Research
Hendrick, Kim C., M.D. (PDF - 441KB) Text Version	05/11/2006	Center for Drug Evaluation and Research
Holland, James A., M.D. (PDF - 983KB) Text Version	09/22/2004	Center for Drug Evaluation and Research
Kapner, Jamie., M.D. (PDF - 603KB) Text Version	08/15/2007	Center for Drug Evaluation and Research
Katz, Lois A., M.D. (PDF - 491KB)	08/21/2000	Center for Drug Evaluation and Research
LaHaye, Leon C., M.D. (PDF - 483KB)	05/11/2001	Center for Devices and Radiological Health
Law, Peter K., Ph.D. (PDF - 489KB)	06/30/2000	Center for Biologics Evaluation and Research
Lofgren, David N., M.D. (PDF - 512KB) Text Version	11/09/2007	Center for Biologics Evaluation and Research
Loucks, David Craig, M.D. (PDF - 104KB) Text Version	8/18/2009	Center for Drug Evaluation and Research
Macapinlac, Manuel, M.D (PDF - 1,003KB) Text Version	02/23/2009	Center for Drug Evaluation and Research
Marcus, Eugenia, M.D. (PDF - 980KB) Text Version	04/22/2004	Center for Biologics Evaluation and Research
Marker, Howard W. M.D. (PDF - 441.91KB) Text Version	01/29/2009	Center for Drug Evaluation and Research
Mathew, Chavaramplakil P., M.D. (PDF - 419.63KB) Text Version	06/27/2001	Center for Drug Evaluation and Research
McGee, J. Michael, M.D. (PDF - 1.04MB)	06/21/2001	Center for Biologics Evaluation and Research
McLeod, Jeffrey L., M.D. (PDF - 407.83KB) Text Version	08/24/2005	Center for Drug Evaluation and Research
Norman, Allyn M., D.O. (PDF - 242.94KB) Text Version	06/27/2002	Center for Drug Evaluation and Research
Nukta, Emad D., M.D. (PDF - 810.37KB) Text Version	09/30/2004	Center for Devices and Radiological Health
Offenberg, Howard L., M.D. (PDF -654.19KB ) Text Version	06/08/2004	Center for Drug Evaluation and Research
Overlie, Paul A. M.D. (PDF - 243.60KB) Text Version	07/31/2007	Center for Devices and Radiological Health
Page, Roy C., M.D. (PDF - 448.95KB)	04/06/2000	Center for Biologics Evaluation and Research
Palazzo, Maria Carmen, M.D., Ph.D. (PDF - 633.68KB) Text Version	12/03/2003	Center for Drug Evaluation and Research
Phillips, Christopher M., M.D. (PDF - 362.92KB) Text Version	01/20/2006	Center for Drug Evaluation and Research
Ramirez, Ramon, M.D. (PDF - 130.86KB) Text Version	10/21/2008	Center for Drug Evaluation and Research
Raval, Pramod, M.D. Text Version	02/21/2008	Center for Drug Evaluation and Research
Redd, Burton L., M.D. (PDF - 395.51KB) Text Version	03/11/2004	Center for Devices and Radiological Health
Riba, Arthur, M.D. (PDF - 281.54KB)	05/19/1999	Center for Drug Evaluation and Research
Rossner, Stephen D., M.D. (PDF - 670.57KB) Text Version	05/10/2006	Center for Drug Evaluation and Research
Runels, Charles E., Jr., M.D. (PDF - 1.10MB) Text Version	08/27/2008	Center for Biologics Evaluation and Research
Sparkuhl, Alexander, M.D. (PDF - 148.94KB)	07/01/1998	Center for Drug Evaluation and Research
Swanson, Todd V., M.D. (PDF - 500.19KB) Text Version	05/05/2004	Center for Devices and Radiological Health
Vestal, James, M.D. (PDF - 536.65KB) Text Version	05/09/2007	Center for Drug Evaluation and Research
Wholey, Mark S., M.D. (PDF - 704.42KB) Text Version	10/21/2005	Center for Devices and Radiological Health
Williams, Joseph L., M.D. (PDF - 152.20KB)	07/01/1998	Center for Drug Evaluation and Research
Wilson, James M., M.D., Ph.D. (PDF - 1.37MB)	11/30/2000	Center for Biologics Evaluation and Research
Zabalgoita, Miguel, M.D., (PDF - 792.72KB) Text version	06/08/2009	Center for Drug Evaluation and Research
Ziering, William H., M.D. (PDF - 472.21KB)	11/06/1998	Center for Drug Evaluation and Research