Speakers

As a management analyst with the U.S. Food and Administration, Ali Shariati conducts assessments related to the Generic Drug User Fee Amendments (GDUFA). These assessments are to determine generic drug pharmaceutical company statuses with relation to their user fee obligations under GDUFA. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry to address a growing number of regulatory challenges.