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OTC marketing for minimum of five years should enable monograph eligibility consideration.

This article was originally published in The Tan Sheet

Executive Summary

OTC MARKETING FOR MINIMUM OF FIVE YEARS EXPECTED TO SATISFY "MATERIAL TIME" requirements of the law relating to the consideration of new conditions of use for monograph eligibility, FDA said in an Oct. 3 Federal Register notice. Published in the form of an advanced notice of proposed rulemaking, the document tentatively concludes that the five-year minimum would apply to products marketed both in and outside the U.S.
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