IND/IDE Review and Management
Wondering if your investigator-initiated study will require an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) application with the FDA? The IND/IDE Review and Management Unit provides a service to evaluate your study, in accordance with applicable regulations, to determine if an official filing with FDA is required. If a filing is required, we will also manage it for you. The IND/IDE Review and Management Unit works closely with the FDA, the investigator, and study staff in the filing and subsequent maintenance of all University held Investigational New Drugs (IND), Investigational Device Exemptions (IDE), SAEs, Protocol Deviations, new studies to existing INDs, annual reports, and any other filings necessary to comply with FDA regulations. The Office of Research Regulatory Affairs IND/IDE Review and Management Unit offers complete regulatory support for investigator-initiated drug or device studies. We will maintain the regulatory relationship between UAMS and the Food and Drug Administration (FDA) throughout the trials, relieving the investigator of the regulatory requirements.
- Jennifer Hixon, Regulatory Affairs Manager (Devices), 501-526-7437
- Melisa G. Clark, Regulatory Specialist II (Drugs), 501-686-8098
- Mandi Tarte, Regulatory Specialist I, 501-686-5190