Anticaries Drug Products for Over-the-Counter Human Use; Use of Intraoral Appliance Models for Compliance With Biological Testing Requirements; Request for Information and Comments

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The Food and Drug Administration (FDA) is requesting information and comments on the use of intraoral appliance (IOA) models as a substitute for the animal caries reduction ("rat caries models") biological test required by the monograph for over-the-counter (OTC) anticaries drug products to demonstrate the availability of fluoride in OTC dentifrice formulations. This notice is part of the ongoing review of OTC drug products conducted by FDA.