Past, present, and future - MBSW Online
Past, present, and future - MBSW Online
Past, present, and future - MBSW Online
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• 4 th April 2011• F2F meeting of our group with the FDA to shareindustry guidelines on the proposed analyses <strong>and</strong>definitions on suicide-related data from C-SSRS• Future• More F2F scientific dialogues with the FDA (nextin September 2011)• Prospective collection of suicide data with a scaleas st<strong>and</strong>ard practice in clinical trials• FDA draft guidance on the statistical analysis ofsuicide-related dataMuncie, IN May 25, 2011 C. Gassmann-Mayer Johnson & Johnson16