Improving Regulatory Cooperation Between the U.S. Food and Drug Administration and the EU

February 27, 2016

Randall Lutter
David Zorn

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Rapid growth in trade and innovation in the medical product arena, as well as lengthening international supply chains for foods and drugs, have accelerated the importance of greater cooperation among governmental entities in different countries. We review the U.S. Food and Drug Administration’s regulatory scope, and characterize the state of cooperation between FDA and European Union entities. We review memoranda of understanding (MOU) between FDA and selected European entities. We analyze available information about FDA’s international cooperation and find that there is very little publicly available information to evaluate the accomplishments and outcomes. Finally, we make practical recommendations for better management of FDA’s international activities so as to improve cooperation between FDA and EU entities in a manner consistent with current federal statutes.