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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 Food and Drug Administration?

The Office of Research Regulatory Affairs Regulatory Unit provides a service to evaluate your study, in accordance with applicable regulations, to determine if an official filing with the Food and Drug Administration is required.

If a filing is required, the Regulatory Unit offers regulatory support by working closely with the Food and Drug Administration, principle investigator, study staff, and monitoring specialists in the filing and subsequent maintenance of all university-held Investigational New Drug application and Investigational Device Exemption applications. Reporting elements include adverse events, protocol deviations, the addition of new studies to existing Investigational New Drug applications, annual reports, and any other filings necessary to comply with Food and Drug Administration regulations. We maintain the regulatory relationship between UAMS and the Food and Drug Administration throughout the life of each clinical trial.

Contact the Office of Research Regulatory Affairs 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 – FAQ
  • Food and Drug Administration Warning letters

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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