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In Brief: OTC anticaries monograph

This article was originally published in The Rose Sheet

Executive Summary

OTC anticaries monograph: Final anticaries rule is expected to be out by late 1995 or early 1996, FDA Office of OTC Drug Evaluation Monograph Review Staff Director William Gilbertson, PharmD, reports at the Nonprescription Drug Manufacturers Association's annual scientific conference Sept. 14. The final monograph will require more drug-like labeling, final formulation testing and bioequivalence requirements, Gilbertson said. He also predicted that the final rule on skin protectant products could be published by early 1996...



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