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.
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.
The Quality Assurance Unit has the mission of maintaining a quality program that ensures UAMS compliance with all federal, state, and local regulations governing the manufacture of human cells, tissues, and cellular and tissue-based products (HCT/P’s).
The quality oversight of non-research activities is provided as a result of quality program mandates under the FDA Good Tissue Practice (GTP) regulations finalized May 25, 2005. These regulations give the agency more authority and oversight over a broader range of tissues and the establishments that process them. The QAU accomplishes its mission through quality assurance and control functions including, but not limited to, education, training, auditing, inspecting, and establishing appropriate procedures.
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 firstname.lastname@example.org.