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# No IND Submitted for Study
- URL: https://www.fdaweb.com/no-ind-submitted-for-study/
- Published: 2025-09-30T12:00:00.000Z
- Updated: 2026-09-14T15:23:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159956

A Bioresearch Monitoring Program inspection at a clinical site operated by **Pamela Den Besten**, DDS, in San Francisco, CA, found that she failed to submit an IND for the conduct of a clinical investigation with an investigational new drug. A 9/19 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pamela-k-den-besten-dds-msuniversity-california-san-francisco-715245-09192025?ref=fdaweb.com) says Den Besten conducted a study of Livionex dental gel without having an IND in place.

She was told to respond with a list of steps she has taken to prevent similar violations in the future.