Regulatory Unit

Wondering if your investigator-initiated study will require an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) application with the FDA?Manuals on a shelf The Regulatory Unit provides a service to evaluate your study, in accordance with applicable regulations, to determine if an official filing with the FDA is required. If a filing is required, we will manage it for you. The Regulatory Unit offers regulatory support by working closely with the FDA, the principle investigator, study staff and study monitors in the filing and subsequent maintenance of all University held Investigational New Drugs (IND), Investigational Device Exemptions (IDE).  Reporting elements include AEs/SAEs, protocol deviations, new studies to existing INDs, annual reports, and any other filings necessary to comply with FDA regulations. We  maintain the regulatory relationship between UAMS and the Food and Drug Administration (FDA) throughout the life of each trial.

 

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