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ASENT 13 th Annual Meeting Outcome Measures to Support Labeling Claims: What is new FDA Guidance?

ASENT 13 th Annual Meeting Outcome Measures to Support Labeling Claims: What is new FDA Guidance?. Elektra J. Papadopoulos, M.D., M.P.H. Study Endpoints and Labeling Development CDER/FDA February 24, 2011. Disclosures. No conflicts. Presentation Outline. FDA review of rating scales

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Endpoint measure - PowerPoint PPT Presentation

ASENT 13 th Annual Meeting Outcome Measures to Support Labeling Claims: What is new FDA Guidance?