From a regulatory standpoint, this isn't just interesting it's a problem. Agencies evaluate drug products. They don't regulate psychotherapy. If a meaningful, inseparable portion of the treatment effect comes from the therapeutic container rather than the molecule, then defining the independent variable becomes genuinely complicated and your development program needs to address that directly.
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The Development Alignment GapWhy Clinical Development Programs Fail Before FDA Ever Reviews the Data A Strategic Perspective on Evidence Generation, Regulatory Alignment, and Development Success Denis Katz, MD Founder, Salience Clinical LLC Executive Summary Over the course of my career, I've participated in and advised development programs across pharmaceuticals, biologics, regenerative medicine, diagnostics, neuroscience...0 Commentaires 0 Parts 205 Vue 0 AperçuConnectez-vous pour aimer, partager et commenter!
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