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Entreprise · 15/10/20011 min de lecture
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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Résumé
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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →