FDA Takes Action Against Individual Dentist
The United States Food and Drug Administration (FDA) has taken action against an individual dentist, Dr. Pamela K. Den Besten, over clinical investigation of a drug in a study known as: "Pilot Study: Oral Microbiome and Dental Plaque Control with Livionex® Dental Gel in Children Undergoing Hematopoietic Stem Cell Transplantation (HSCT)”. The FDA found that Dr. Den Besten did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), governing the conduct of clinical investigations and the protection of human subjects. You can read the FDA action here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pamela-k-den-besten-dds-ms-715245-09192025.
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