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.
Laura Adkins, MAP, CCRP, CCRA
Director of ORRA
Brenda Gannon, Ph.D.
Manager of Regulatory Affairs and QA
Janet Storment, RN, CCRP
Research Regulatory Specialist III
Seema Verma, Ph.D.
Research Regulatory Specialist II
Kacy Wright, Ph.D.
Research Regulatory Specialist I