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thank you for the introduction once again my name is Jean men and I will be discussing Prescription Drug User Fee Act for waivers exemptions and refunds oh my my team is involved in to user fee programs the Prescription Drug User Fee Act known as Padova and a biosimilar User Fee Act and today but today Ill be only going over Purdue for user fee program some topics Ill be discussing Ill be going over some of the background information providing some history on Purdue fer where it comes from and what authority gives FDA Ill explain the different types of fees that are currently under Purdue feh Ill be going over when and how fees are collected then Ill talk about waivers exemptions and refunds the different types and what criteria in order to qualify for them and then Ill explain some of the technical administrative aspects of where when and what to submit so some background information on Purdue Phi if youre unfamiliar with it please know it comes from the Food Drug and Cosmeti
