FDA - Disqualified Clinical Investigators

This search covers the FDA Debarred Clinical Administrators.

FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts ("clinical investigators") who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and, for research involving human subjects, to help protect the rights, safety, and welfare of those subjects.

In certain situations, in which FDA alleges a clinical investigator has violated applicable regulations, FDA may initiate a clinical investigator disqualification proceeding.

Our FDA – Disqualified Clinical Investigators search provides a list of clinical investigators who are or have been subject to an administrative clinical investigator disqualification action and indicates the current status of that action.