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DRAFT SLIDES FOR NDA 21-198 ADVISORY COMMITTEE PRESENTATIONS

DRAFT SLIDES FOR NDA 21-198 ADVISORY COMMITTEE PRESENTATIONS. Joint Advisory Committee Meeting FDA Presentations. Clinical Efficacy and Safety Mary H. Parks, MD (DMEDP) Actual-Use Trials Daiva Shetty, MD (DOTCDP) Label Comprehension Studies Karen Lechter, JD, PhD (DDMAC).

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DRAFT SLIDES FOR NDA 21-198 ADVISORY COMMITTEE PRESENTATIONS