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OTC anticaries final rule slated for June release -- FDA regulatory agenda.

This article was originally published in The Rose Sheet

Executive Summary

OTC ANTICARIES FINAL RULE DUE OUT IN JUNE according to FDA's "unified agenda" published in the May 8 Federal Register. The final monograph is expected to include formulation testing and bioequivalence requirements for products. While it will not require manufacturers to submit a new drug application to support efficacy, the monograph is expected to require them "to follow specific" guidelines outlined in the final rule, FDA Monograph Review Staff Director William Gilbertson, PharmD, said in June 1994 as he discussed the status of various monographs the agency has been working on.
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