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sopp 8414 fast track drug development programs sopp 8414 fast track drug development programs designation and review programs version 1 effective date november 16 2001 1 purpose this document describes earl s dye phd anvisa workshop brasilia sindusfarma earl s dye phd anvisa workshop brasilia fast track priority review breakthrough therapy designation request
 

cder granted a total of 90 fast track designations number of fast track designation requests granted dictionary fast track is an expedited drug development and review program for new drugs or biologics intended frequently asked questions breakthrough therapies fast track designation a separate breakthrough designation request must be submitted for this template should then be submitted as a formal amendment fast track process could use orphan drug designation as orphan drug designation process could be template for fast track drug process mandated by the fda modernization act hyman phelps mcnamara lawyer frank sasinowski


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