Brilinta Advisory Cmte. Nod Creates Postmarketing Study Quandary For FDA
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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