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Antiplaque/antigingivitis OTC Review

This article was originally published in The Tan Sheet

Executive Summary

Final formulation testing requirement assessment on case-by-case basis for ingredients/combos included in final category monograph recommended by the NDMA/CTFA Oral Care Task Group in May 19 comments to FDA. A variety of in vitro and in vivo studies, ranging from animal tests to human clinicals, may be appropriate tests, the group says, adding it is the responsibility of companies to provide the testing rationale. The task group plans to present its recommendations for final formulation testing, labeling and combo products at FDA's NDAC Plaque Subcommittee meeting May 27-29. The committee discussed case-by-case standards for final formulation testing at its last meeting in October ("The Tan Sheet" Nov. 3, 1997, p. 6)...
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