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Research and Innovation: Office of Research Regulatory Affairs

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?

UAMS Office of Research Regulatory Affairs (ORRA) Regulatory Unit will 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 (for IND and Significant Risk IDE studies), Principal Investigator, study staff, and ORRA monitoring specialists throughout the life of the IND/IDE study to file and maintain necessary documentation and submit all required reports, including adverse events, protocol deviations, the addition of new studies to existing Investigational New Drug applications, annual reports, and any other elements necessary to comply with FDA regulations.

We maintain the regulatory relationship between UAMS and the FDA throughout the life of each clinical trial.

We also provide guidance/assistance with IRB submission and follow-up.

Contact ORRA Regulatory Unit at ORRARegulatoryUnit@uams.edu.

Staff Contacts

  • Brenda Gannon, Ph.D.
    Manager of Regulatory Affairs and QA
    BGannon@uams.edu
    501-686-5190
  • Seema Verma, Ph.D.
    Research Regulatory Specialist II
    SVerma@uams.edu
    501-526-7437

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