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RUSSIA AGREES TO ADOPT "STREAMLINED" DRUG REVIEW BASED ON U.S. APPROVAL

This article was originally published in The Tan Sheet

Executive Summary

RUSSIA AGREES TO ADOPT "STREAMLINED" DRUG REVIEW BASED ON U.S. APPROVAL in a memorandum of understanding (MOU) signed on Feb. 15 by FDA and Russia's Ministry of Health and Medical Industry. The MOU calls for Russian regulatory authorities to "accept FDA's decisions and regulations on premarket approval, licensing, monographs, and related matters, as well as FDA's product quality standards and enforcement of manufacturing" for drugs or biologicals made in the U.S.
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