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?

The ORRA 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, the Regulatory Unit offers regulatory support by working closely with the FDA, principle investigator, study staff, and monitoring specialists in the filing and subsequent maintenance of all University-held IND and IDE applications.  Reporting elements include adverse events, protocol deviations, the addition of 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 FDA throughout the life of each clinical trial.

Contact the ORRA Regulatory Unit!

 

Staff Contacts:

Melisa Clark, MS, CCRP, RAC, Regulatory Affairs Manager & Quality Assurance, 501-686-8098

Brenda Gannon, Ph.D., QA Research Regulatory Specialist III, 501-686-5190

 

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