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Data Request: Use of the pH Cycling Test Model as a Testing Procedure for Fluoride Dentifrice Drug Products in Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use

🏛 Food and Drug Administration (FDA)FDA-2026-N-7864
Pharmaceutical PolicyProduct Safety & Recalls
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📄 Primary document
OtherJul 28, 2026
Data Request (DR001): Use of the pH Cycling Test Model as a Testing Procedure for Fluoride Dentifrice Drug Products in Over-the-Counter (OTC) Monograph M021: Anticaries Drug Products for Over-the-Counter Human Use
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