Yiming Li, DDS, PhD, MSD, associate dean for Research, and director, Center for Dental Research (CDR), received a letter (05/09/2016) from the US Food and Drug Administration (FDA) on Department of Health & Human Services stationery, regarding an FDA “inspection conducted at your site (1/13/2016-1/19/2016).”
The CDR conducts multiple clinical studies annually, which include FDA clinical trials that are subject to inspection by the FDA. An FDA inspector reviewed the CDR’s conduct of two multi-center, randomized, double-blind, parallel-groups clinical trials that compared the efficacy of the investigational drug Tetracaine 3% and Oxymetazoline 0.05% Nasal Spray (Kovanaze®) to a placebo for anesthetizing maxillary teeth in adult patients and in pediatric patients.
Besides Dr. Li being the principal investigator and Ms. Michele Arambula serving as the project coordinator for these two projects, a number of faculty served as co-investigators, including Sean Lee, DDS, professor and associate director, Center for Dental Research; Michael Meharry, DDS’80, assistant professor, Clinical Care Faculty, Midwestern University College of Dental Medicine–Arizona; Jung-Wei Chen, DDS, MS, PhD, MS, program director, Advanced Specialty Education Program for Pediatric Dentistry; Bonnie Nelson, DDS’88, chair, Department of Pediatric Dentistry; and Samah Omar, DDS’07 (IDP), associate professor, Pediatric Dentistry.
The inspection was conducted as part of the FDA’s Bioresearch Monitoring Program designed to evaluate the conduct of FDA-regulated research to ensure that the data are scientifically valid and accurate, and to help ensure that the rights, safety, and welfare of the human subjects of those studies are protected.
“Following our review,” the FDA regulatory health project manager concluded, the CDR “adhered to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”