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Brilinta Advisory Cmte. Nod Creates Postmarketing Study Quandary For FDA

Executive Summary

With the Cardiovascular and Renal Drugs Advisory Committee's endorsement of AstraZeneca's antiplatelet agent Brilinta (ticagrelor) behind it, FDA now faces a potential challenge in devising a postmarketing study commitment aimed at addressing efficacy questions in U.S. acute coronary syndrome patients that does not also run into ethical roadblocks

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