FDA's acceptance of Latin America, Asia data for "material time/extent" criteria urged.
This article was originally published in The Rose Sheet
Executive Summary
FDA ACCEPTANCE OF LATIN AMERICA, ASIA FOREIGN USE DATA URGED by the Nonprescription Drug Manufacturers Association in Dec. 30 comments on the agency's proposed criteria defining the terms to "a material time" and for "a material extent," with regard to the approval of new OTC "conditions of use," such as active ingredients, indications and dosage forms, for nonprescription drugs reviewed within the monograph system. "It is the quality and detail of the marketing data, rather than its conformance to preconceived notions of source or culture, that should be the touchstone of acceptability," NDMA maintains in its support for foreign use data from Latin America and Asia.
You may also be interested in...
OCA Applauds Organic Board's Recommendation To USDA: "Outlaw Nanotech"
With a push from the Organic Consumers Association, the National Organic Standards Board is recommending that the use of nanotechnology be strictly prohibited from products certified under the National Organic Program
Beauty Claims Inch Closer To Pharma As Cosmeceutical Sector Expands
Though global market-size estimates differ, analysts at SupplySide West 2010 in Las Vegas agreed that cosmeceuticals remain a promising growth vehicle
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