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OTC "material time, material extent" tentative criteria allow drug export countries' data.

This article was originally published in The Tan Sheet

Executive Summary

FDA "MATERIAL TIME, MATERIAL EXTENT" CRITERIA FOR OTCs would allow acceptance of foreign marketing data from countries designated as appropriate recipients of U.S. drug exports under the recently revised Drug Export Amendments of 1986, according to an Oct. 3 FDA Federal Register notice. Australia, Canada, New Zealand and the U.K. are among the 24 "tier one" countries under the drug export law. FDA is interested in feedback on whether marketing experience from countries outside that list also should be considered.
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