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

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.

The NIDPOE Letters are arranged in order by date, with the most recent letter added to the top of the list. Additional NIDPOE Letters are available from the FDA Freedom of Information Reading Room, NIDPOE Letters.

2004

Marcus, Eugenia, M.D. - 4/22/2004 - (PDF - 979 KB)

2003

Daley, Patrick J., M.D. - 6/23/2003 - (PDF - 1 MB)

2002

Chang, Alfred E., M.D. - 11/6/2002 - (PDF - 1 MB)

2001

McGee, J. Michael, M.D. - 6/21/2001 - (PDF - 1 MB)

2000

Wilson, James M., M.D., Ph.D. - 11/30/2000 - (PDF - 1 MB)
Law, Peter K., Ph.D. - 6/30/2000 - (PDF - 488 KB)
Page, Roy C., M.D. - 4/6/2000 - (PDF - 448 KB)

 
Updated: November 26, 2007