In Brief: Anticaries final monograph
This article was originally published in The Tan Sheet
Executive Summary
Anticaries final monograph: FDA stays OTC fluoride dentifrice biological testing procedures until Oct. 7, 1997 "to provide manufacturers an additional 12 months to comply," according to a Dec. 16 Federal Register notice. The requirements were set forth in an October 1995 final monograph for OTC anticaries drugs ("The Tan Sheet" Oct. 9, 1995, pp. 9-10); the extension grants the request of an April petition submitted by the Joint Oral Task Group of the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry & Fragrance Association ("The Tan Sheet" April 1, p. 12)...