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 | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-N-7864

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

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensJul 28, 2026

Comment Period ClosesJan 26, 2027

Documents

Type	Title	Posted	Comments	Status
Other	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	Jul 28, 2026	--

Keywords

CDER

Notice

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

Data from Regulations.gov