FDA OTC "material time, material extent" tentative criteria includes foreign marketing data.
This article was originally published in The Rose Sheet
Executive Summary
FDA OTC "MATERIAL TIME, MATERIAL EXTENT" TENTATIVE CRITERIA INCLUDES FOREIGN MARKETING experience to qualify a specific "condition of use" for consideration under the OTC monograph system. The long-awaited notice, published in the Federal Register Oct. 3 as an advanced notice of proposed rulemaking, begins the process of amending the agency's statutory definition of what constitutes marketing to a `material extent' and `for a material time' for reviewing new OTC conditions of use such as ingredients, indications, routes of administration and dosage forms under a monograph.
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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