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FDA and European Union fail to reach agreement on good manufacturing practices (GMP):

This article was originally published in Clinica

Executive Summary

US FDA and European Union officials meeting in Brussels early this month made no progress in their efforts to harmonise Good Manufacturing Practices and final marketing decisions for medical devices. A meeting last November also ended in a stalemate. US representatives distributed a paper at the June session that "clarified and refined" the agency's earlier position, a source says, although it failed to impress the Europeans. American bureaucrats say they feel it would be "premature" to move ahead on mutual recognition agreements until a planned pilot programme of third-party review has been completed and assessed. Nevertheless, delegates issued a joint paper and agreed to continue discussions.





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