Anticaries Contemporary Protocols Recognition By FDA Sought By CTFA/CHPA
This article was originally published in The Rose Sheet
Executive Summary
The Cosmetic, Toiletry and Fragrance Association and the Consumer Healthcare Products Association are seeking FDA approval of procedural variations to three existing anticaries final formulation testing protocols. The request was the subject of an OTC "feedback" meeting in Rockville, Md. April 12.
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Anticaries protocol
CTFA requests FDA confirm that "contemporary" protocols are compliant with the biological testing of anticaries drug products accepted in the final monograph. The Dec. 14 request, which was submitted jointly by CTFA and the Consumer Healthcare Products Association, answers technical questions asked by the agency in an April 30, 1999 "feedback" letter regarding the three existing methods of protocol: animal caries reduction, enamel solubility reduction and enamel fluoride uptake. The issue was the subject of an OTC "feedback" meeting April 12 (1"The Rose Sheet" April 19, 1999, p. 10). The trade groups note a working group meeting may be needed to resolve outstanding questions
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