Preview of Clinical Precedent (Disqualified and debarred). This is the page subscribers use. The counts are the FDA record; the lists themselves, with every proceeding and document, are for subscribers.
Disqualified and debarred
The two FDA actions that can end a clinical investigator’s eligibility — disqualification (a regulatory proceeding that starts with a NIDPOE letter and can bar a clinical investigator from receiving investigational products) and debarment (a statutory penalty tied to criminal conviction). Every proceeding on record, its outcome, and the underlying FDA documents where available.
Disqualification proceedings
A NIDPOE (Notice of Initiation of Disqualification Proceedings and Opportunity to Explain) opens the case; a NOOH (Notice of Opportunity for Hearing) escalates it; the status shows how it ended. Proceedings span all FDA centers — a disqualification bars the clinical investigator regardless of product type.
| Clinical investigator | Center | Location | Status | Status date | NIDPOE | NOOH | Documents |
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Debarment list
Debarment under FD&C Act §306 follows a criminal conviction connected to drug products. It is a separate track from disqualification, and reaches beyond clinical investigators (pharmacists, executives, submission fraud) — but several clinical investigators appear on both lists. A person FDA has since taken off its list stays here, marked as no longer on it.
| Name | Effective | Term | Status | Order |
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