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CTFA recommends material time five-year marketing requirement as "guideline".

This article was originally published in The Rose Sheet

Executive Summary

MATERIAL TIME FIVE-YEAR MARKETING REQUIREMENT "APPROPRIATE" AS GUIDELINE but "not an inviolable rule," the Cosmetic, Toiletry and Fragrance Association maintains in comments submitted to FDA. The comments respond to the agency's proposal to include foreign marketing information in support of new U.S. OTC conditions of use (including ingredients, indications and dosage forms). Published in the Oct. 3 Federal Register, the advanced notice of proposed rulemaking sets out criteria defining "for a material time" and "to a material extent" for use in reviewing foreign data.
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