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. 2019 Mar 2;12(4):361–370. doi: 10.1111/cts.12617

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© 2019 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Regulatory overview of novel therapeutic drugs approved based on a single pivotal trial. Overview of regulatory pathways and designations for novel therapeutic drugs for which one or more indications were approved based on a single pivotal trial by the US Food and Drug Administration Center for Drug Evaluation and Research and/or via the European Medicines Agency Centralized Procedure between 2012 and 2016. Color shading signifies drugs fulfilling study selection criteria in the European Union (EU) only (blue shading), in both regions (no shading), and United States (US) only (red shading). 3TC, Lamivudine; ABC, Abacavir; DTG, dolutegravir; NAS, New Active Substance; NME, New Molecular Entity; N/A, not applicable.