🧪FDA Announces Public Meeting on Unapproved Fluoride Prescription Drugs
Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population." The purpose of the hybrid public meeting is to seek public input on the clinical use and safety concerns associated with the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population. The public meeting will be facilitated by the Reagan-Udall Foundation for the FDA. FDA is establishing a docket for public comment on this topic.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's announcement regarding the use of unapproved prescription fluoride drugs for children suggests impending regulatory changes and safety assessments, which may require businesses involved in pharmaceuticals or pediatric health to comply with new regulations and adjust product offerings.