FDA international memorandum of understanding policy formalized.
This article was originally published in The Gray Sheet
Executive SummaryFDA MEMORANDUM OF UNDERSTANDING POLICY FORMALIZED in a compliance policy guide published in the June 15 Federal Register. Formulated in response to a recommendation in a December 1992 report of the agency's International Harmonization Task Force ("The Gray Sheet" Jan. 25, 1993, p. 6), the policy outlines general principles for developing MOUs with foreign governments and international organizations, as well as procedures for initiating and monitoring such agreements.
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