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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) are set out 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.

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

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