(精选)【甲流H1N1精品课件】 CBER Regulatory Approaches Activities To Support Licensure of Pandemic (H1N1) 2009 Vaccine教学课件.ppt

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2018-03-21 发布于天津
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(精选)【甲流H1N1精品课件】 CBER Regulatory Approaches Activities To Support Licensure of Pandemic (H1N1) 2009 Vaccine教学课件.ppt

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VACCINES AND RELATEDBIOLOGICAL PRODUCTS ADVISORY COMMITTEE;Presentation Outline;Pandemic (H1N1) 2009 Vaccine Considerations;Currently Licensed Influenza Vaccines in U.S.;Available Regulatory Pathways for use of Pandemic (H1N1) 2009 Influenza Vaccine;Licensure of Seasonal Influenza Vaccine - Strain Change Supplement;Licensure of Unadjuvanted Monovalent Pandemic (H1N1) 2009 Vaccines Made by Licensed Process;Licensure of Unadjuvanted Monovalent Pandemic (H1N1) 2009 Vaccines Made by Licensed Process;Clinical Trial Basic Design;Clinical Trial Endpoints;Emergency Use Authorization;Emergency Use Authorization;Summary;Summary (cont’d); FDA is committed to protecting the public’s health and ensuring the availability of safe and effective vaccines for our nation against the pandemic H1N1 2009 virus as quickly as possible.;Acknowledgment