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In Brief: Anticaries products final monograph

This article was originally published in The Rose Sheet

Executive Summary

Anticaries products final monograph: FDA postpones compliance date for testing procedures requirement under the final monograph for a year until Oct. 7, 1997. The postponement responds to an April 17 Nonprescription Drug Manufacturers Association and Cosmetic, Toiletry and Fragrance Association citizen petition, which requests that the agency stay the biological testing requirements for OTC fluoride dentifrice products for an additional year past the Oct. 7, 1996 effective date ("The Rose Sheet" Sept. 30, p. 13). The petition was supported by a Sept. 5 survey that pointed out that 37 products remained to be tested, and each would take about three to four months to conduct. The last test is scheduled to begin in February...
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