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.
- 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
- 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