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In Brief: U.S. trade barriers for OTCs

This article was originally published in The Tan Sheet

Executive Summary

U.S. trade barriers for OTCs: Process of obtaining FDA OTC drug approval for a new medicinal product in the U.S. is hampered by the requirement for a U.S. market history for the product, the European Commission 1997 Report on United States Barriers to Trade and Investment states. Also, the problem of admission of European suntan lotions to the U.S. market continues, the reports says, adding that "while the FDA did approve sunscreen products containing avobenzone in concentrations of up to 3%, final monographs covering this and other sunscreen products are still pending." BASF, Merck and Haarman & Reimer jointly and separately have been attempting to facilitate marketing of foreign OTC products in the U.S. ("The Tan Sheet" Jan. 13, pp. 8-9)...

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