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Documents Single Use Expanded Access IND/IDE: FDA and IRB Requirements Before and After Use IRB Webinar...

Slide 1 Single Use Expanded Access IND/IDE: FDA and IRB Requirements Before and After Use IRB Webinar October 9,2014 Slide 2 Objectives  Help you navigate through the…

Documents Expanded Access Programs for Drugs and Biologics...

Slide 1 Expanded Access Programs for Drugs and Biologics _________________________________________________________ Richard Klein Office of Health and Constituent Affairs…

Documents Richard Klein Office of Health and Constituent Affairs Food and Drug Administration

Expanded Access Programs for Drugs and Biologics _________________________________________________________ Richard Klein Office of Health and Constituent Affairs Food and…