OTC anticaries final rule slated for June release -- FDA regulatory agenda.
This article was originally published in The Rose Sheet
Executive Summary
OTC ANTICARIES FINAL RULE DUE OUT IN JUNE according to FDA's "unified agenda" published in the May 8 Federal Register. The final monograph is expected to include formulation testing and bioequivalence requirements for products. While it will not require manufacturers to submit a new drug application to support efficacy, the monograph is expected to require them "to follow specific" guidelines outlined in the final rule, FDA Monograph Review Staff Director William Gilbertson, PharmD, said in June 1994 as he discussed the status of various monographs the agency has been working on.
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Marketing In Brief
ModiFace launches forecasting tool: Toronto-based virtual makeover firm introduces ShadeCast, a makeup sampling and forecasting tool based on behavioral tracking. ShadeCast is used in conjunction with iPhone application MakeUp, which allows consumers to virtually try on makeup in hundreds of shades from brands including Revlon, Cover Girl, Lancome and Clinique. ShadeCast offers 1,000 cosmetic shades from 40 brands and assigns a ShadeScore "to approximately position the [app's] hottest and most sampled color." ModiFace exec Nikkie Gatto likens the app to radio music playlists, helping consumers "looking to capture the current look, but also provide vital market intelligence to our retail channel partners," she says in Nov. 3 release. "The value of data to demonstrate the aggregate behavior will help the industry predict the latest trends and help cosmetic manufacturers better understand the color and products which most resonate with online and iPhone virtual makeover users," the company says