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Tuteur & Associates, LLC | Knowledge is Power.
October 2, 2006
Bayer has acknowledged that it mistakenly did not inform the U.S. Food and Drug Administration prior to a recent FDA Advisory Committee meeting about a retrospective observational study commissioned by the company to analyze the effects of aprotinin, aminocaproic acid and tranexamic acid in patients undergoing coronary artery bypass graft (CABG) surgery. This data was not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology. Continue reading, ‘10-02-2006 | Current Trasylol® (aprotinin injection) News.’