 
FDA and Reagan-Udall Foundation Announce Public Meeting on the Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population
The U.S. Food and Drug Administration, in cooperation with the Reagan-Udall Foundation for the FDA, will convene a hybrid public meeting to gather input on the clinical use and safety concerns associated with orally ingestible unapproved prescription drug products containing fluoride for use in children.
The hybrid public meeting will take place July 23, 2025 from 9:30am - 4pm ET.
The public is invited to provide brief comments on four key topics related to the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population.
- Clinical Use and Prescribing Considerations for Pediatric Tooth Decay Prevention
- Safety Concerns
- Appropriateness of Pediatric Use Considering Additional Sources of Exposure
- Impact of Removal of Orally Ingestible Unapproved Prescription Drug Products/Potential Alternatives
Written comments can be submitted to the federal docket and members of the public may also request an opportunity to provide comments during the meeting. The public comment request deadline is Wednesday, July 9, 2025.
To view the Federal Register Notice, please .
For additional information on the meeting including how to register, please click here.
About Us
The Public Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, patients and patient advocacy organizations, consumer groups, trade associations, think tanks and academia, and other interested parties, in order to better inform our policy making process, identify policy hurdles or misconceptions, and create strategic collaborations. For more information, please contact us at PublicEngagement@fda.hhs.gov. For patient specific inquiries, please contact us at Patients Ask FDA.
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