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Research and Innovation: Office of Research Regulatory Affairs
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  1. University of Arkansas for Medical Sciences
  2. Research and Innovation
  3. Office of Research Regulatory Affairs
  4. Departments
  5. Regulatory Affairs
  6. Regulatory Unit

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

  • Laura Adkins, MAP, CCRP, CCRA
    Director of ORRA
    LLAdkins@uams.edu
    501-686-6092
  • Brenda Gannon, Ph.D.
    Manager of Regulatory Affairs and QA
    BGannon@uams.edu
    501-686-5190
  • Janet Storment, RN, CCRP
    Research Regulatory Specialist III
    StormentJanetS@uams.edu
    501-686-7976
  • Seema Verma, Ph.D.
    Research Regulatory Specialist II
    SVerma@uams.edu
    501-526-7437
  • Kacy Wright, Ph.D.
    Research Regulatory Specialist I
    KWright@uams.edu
    501-603-1206

Links

  • Food and Drug Administration – Main page
  • Food and Drug Administration Warning letters
  • Food and Drug Administration Form 1572
  • MedWatch 3500A
  • E6(R3) Good Clinical Practice Guidelines
  • 21 Code of Federal Regulations Part 312 (Drugs)
  • 21 Code of Federal Regulations Part 812 (Devices)
  • Expanded Access Program (Drugs)
  • Expanded Access Program (Devices)
  • Guidance for IND Determination
  • Information on Non-Significant and Significant Risk Devices

Subpages

  • Investigational Device Exemption Submission
  • Investigational New Drug Submission
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Mailing Address: 4301 West Markham Street, Little Rock, AR 72205
Phone: (501) 686-7000
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