Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Pamela K. Den Besten was cited for conducting a clinical investigation of Livionex® Dental Gel, an investigational drug, without submitting a required Investigational New Drug (IND) application to the FDA. The inspection, conducted September 16–October 15, 2024, found that she failed to comply with 21 CFR 312.20 and 312.40(a) by initiating a human subject study (Protocol 15-18297 evaluating oral microbiome and dental plaque control in pediatric stem cell transplant patients) without obtaining FDA authorization through an IND submission. This violation of the Federal Food, Drug, and Cosmetic Act undermined protections for research subject safety and rights that the FDA's Bioresearch Monitoring Program is designed to ensure.