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U.S. Department of Health and Human Services

Regulatory Information

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Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE)

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, 12420 Parklawn Drive, ELEM-1029, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at 

http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm

 

NameDate IssuedIssuing 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

Aldrich, Harrison F., M.D. (PDF - 10.1MB)

Text Version

02/24/2003Center for Drug Evaluation and Research

Alexander, Elmore, D.O. (PDF - 207KB)

Text Version

01/27/2012Center for Drug Evaluation and Research
Allman, Richard M., M.D. (PDF - 354KB) Text Version
07/10/1998
Center for Drug Evaluation and Research
Anderson, Roger D., M.D. (PDF - 268KB) Text Version
09/13/2000
Center for Drug Evaluation and Research

Berger, Daniel S., M.D. (PDF - 152.67KB) Text Version

11/27/2009Center for Drug Evaluation and Research
Berger, Michael D., M.D. (PDF- 335.60KB) Text Version 09/26/2011Center for Biologics 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
Candal, Francisco, M.D. (PDF - 79.00KB) Text Version03/02/2011Center 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) Text Version
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)Text Version

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

Holmes, Amy M.D. (PDF - 74.37KB)

Text Version

12/02/2010Center 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)

Text Version

05/11/2001
Center for Devices and Radiological Health

Lasala, Gabriel P., M.D. (PDF - 26.34KB)

Text Version

 02/16/2012Center for Biologics Evaluation and Research

Law, Peter K., Ph.D. (PDF - 489KB)

Text

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
08/18/2009Center for Drug Evaluation and Research
Lu, Eugene, MD. (PDF)
Text Version
03/16/2010Center 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
Mendolia, Thomas, D.O. (PDF 763.70KB) Text Version 11/22/2011 Center for Drug Evaluation and Research
Niederman, Alan., M.D. (PDF - 867.97KB
Text Version
11/01/2010Center for Biologics 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

Pierce, Keith J., M.D. (PDF - 78.4KB)

Text Version

03/17/2010Center 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.
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

Reuben, Scott S., M.D. (PDF - 38.8KB)

Text Version

03/17/2010Center for Drug Evaluation and Research
Riba, Arthur, M.D. (PDF - 281.54KB)
05/19/1999
Center for Drug Evaluation and Research

Richards, Jon, M.D. (PDF -2.20MB)

Text Version

08/28/2012Center 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

Saadeh, Ghandi M., M.D.

Text Version

01/04/2010Center for Drug Evaluation and Research
Sparkuhl, Alexander, M.D. (PDF - 148.94KB)
07/01/1998
Center for Drug Evaluation and Research

Spencer, Wayne E., M.D. (PDF - 372KB)

Text Version

04/20/2011Center for Biologics 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
06/08/2009Center for Drug Evaluation and Research
Ziering, William H., M.D. (PDF - 472.21KB)
11/06/1998
Center for Drug Evaluation and Research

 

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