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PDUFA VI “Breakthrough” Fee Unlikely; FDA Wants Fewer Obligations, Not New Metrics

This article was originally published in RPM Report

Executive Summary

FDA Office of New Drugs Director John Jenkins is making a case against adding “Breakthrough” user fees to PDUFA VI to better fund the program and cut back on the number of unqualified requests for designation. Rather than seek additional funding for specific programs, FDA wants fewer obligations under the user fee program; the agency is pushing back against industry proposals to add more formal meetings.


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