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J.jacbts.2018.06.001

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JACC: BASIC TO TRANSLATIONAL SCIENCE VOL. 3, NO. 4, 2018 ª 2018 THE AUTHORS. PUBLISHED BY ELSEVIER ON BEHALF OF THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY-NC-ND LICENSE (http://creativecommons.org/licenses/by-nc-nd/4.0/). TRANSLATIONAL PERSPECTIVES Pharmacogenetic Labeling of FDA-Approved Drugs A Regulatory Retrospective Katarzyna Drozda, PHARMD, MS, Michael A. Pacanowski, PHARMD, MPH, Christian Grimstein, PHD, Issam Zineh, PHARMD, MPH SUMMARY The U.S. Food and Drug Administration recently marked 10 years since first updating the labeling for warfarin (often referred to as the “poster child” of pharmacogenomics) to include information regarding the potential impact of CYP2C9 and VKORC1 genetic variation on warfarin dosing requirements and risks. Herein, we opine on the experience updating the warfarin labeling, highlighting more generally the enabling factors and challenges encountered when considering incorporation of pharmacogenomic information into the prescribing recommendations for already approved drugs. We also provide a historical perspective of implemented changes in regulatory policies related to personalized medicine. (J Am Coll Cardiol Basic Trans Science 2018;3:545–9) © 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). P recision medici ...
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