NIDPOENotice of Initiation of Disqualification Proceedings and Opportunity to Explain (FDA)
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The NIDPOE letter outlines the allegations of Investigator Misconduct and provides the investigator a deadline by which to respond to the allegations, either in writing or during an informal meeting with FDA officials.
Alternatively, rather than offering an explanation of the Investigator Misconduct alleged in the NIDPOE letter, the investigator may attempt to negotiate a consent agreement with FDA.