UAMS.EDU

Regulatory Affairs

FDA Regulatory Review

The Regulatory Affairs team offers complete regulatory support for investigator-initiated drug or device studies.  UAMS acts as the sponsor for all INDs and IDEs filed on behalf of our investigators. The group provides a number of support services including regulatory evaluation, quality assurance compliance, and monitoring. The Regulatory Affairs team, in concert with other UAMS regulatory compliance departments, ensures that IND and IDE studies remain in compliance as required under Title 21 of the Code of Federal Regulations.

 INDs/IDEs

The IND/IDE team, in accordance with applicable regulations, will review your study to determine the need for an Investigational New Drug application (IND) or an Investigational Device Exemption (IDE).  If an IND or IDE is required, we will work with the Principal Investigator and their staff to compile, build, file, and manage the IND/IDE submission. We also provide assistance with activities such as orphan drug applications and submissions, compassionate use drug or device requests, and FDA Pre-IND/IDE meeting support.

Quality Assurance

QA specialists work with investigators and their staff to ensure compliance with quality aspects of research as set forth by Good Manufacturing Practices (GMP), Good Tissue Practices (GTP), and Good Laboratory Practices (GLP).  We help with the development and maintenance of Standard Operating Procedures (SOPs), processing records, and controls.  We can plan and facilitate the qualification/validation of equipment, facilities, assays, and software to meet regulatory requirements as well as provide assistance with environmental control & monitoring and the release for use of IND products manufactured by UAMS.  We also provide support with ClinicalTrials.gov registration and maintenance for those investigators conducting research under a UAMS-sponsored IND or IDE.

Monitoring

Monitors are responsible for monitoring all UAMS-sponsored investigator-initiated IND/IDE research studies.  In addition to conducting periodic monitoring visits throughout the course of your study, we can provide assistance with the preparation of essential study documents (regulatory binders, source documentation, case report forms, etc.), site initiation visits, closeout visits, and audit preparations.  The monitoring team aims to ensure quality data collection, adherence with the investigational plan, and compliance with applicable regulations.

 

Contact the Regulatory Affairs team at regulatoryaffairs@uams.edu.