Sponsor-Investigator Gets Warning After Failing to Submit IND

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Sponsor-Investigator Receives Warning Letter After Allegedly Failing To Submit IND for Trial

J.W. Schomisch

October 5, 2025 at 03:53 PM EST

A sponsor-investigator received an FDA Warning Letter alleging the investigator failed to submit an Investigational New Drug application (IND) for a clinical trial. The sponsor-investigator, Dr. Pamela Den Besten, a dentist with the University of California-San Francisco, conducted “Pilot Study: Oral Microbiome and Dental Plaque Control with Livionex® Dental Gel in Children U... Read More

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Sponsor-Investigator Receives Warning Letter After Allegedly Failing To Submit IND for Trial

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