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EUA: CDC s Roles and Responsibilities

Supports the critical task of ensuring availability, distribution, and utilization of medical countermeasures (MCMs)Engages FDA and other federal/state partners to develop and establish mechanisms to facilitate widespread availability and timely access of MCMsRegulatory StrategyOperations and Lo

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EUA: CDC s Roles and Responsibilities

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    1. Yon Yu, Pharm.D. Deputy Associate Director, Regulatory Affairs National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention Federal, State and Local Public Health Preparedness Meeting: Legal and Regulatory Perspectives, December 14, 2010 EUA: CDC’s Roles and Responsibilities

    2. Supports the critical task of ensuring availability, distribution, and utilization of medical countermeasures (MCMs) Engages FDA and other federal/state partners to develop and establish mechanisms to facilitate widespread availability and timely access of MCMs Regulatory Strategy Operations and Logistics EUA: CDC’s Roles & Responsibilities

    3. Submits pre-EUA and EUA requests to FDA preEUA/EUA is product-specific for a threat agent Includes available data to support MCM use Dynamic process Provisional agreements on EUA conditions Communication Planning/Strategy Experiences to Date: 14 preEUA and 6 EUA requests 2009 President’s Inauguration 2009 H1N1 Public Health Emergency EUA: CDC’s Roles & Responsibilities

    4. Sharing of lessons learned from all stakeholders to enhance preparedness regarding stockpiling, distribution, dispensing, and utilization of MCM Engage in transparent and continuing dialogues among all stakeholders Next Steps

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