Heidi Alexander: “I ask unanimous consent to have printed in the Record a copy of the commitment letter for the Prescription Drug User Fee…”

“I ask unanimous consent to have printed in the Record a copy of the commitment letter for the Prescription Drug User Fee Act, PDUFA, reauthorization for fiscal years 2018 to 2022, known as PDUFA VI. There being no objection, the material was ordered to be printed in the Record, as follows: PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2018 THROUGH 2022 I. Ensuring the Effectiveness of the Human Drug Review Program A. Review Performance Goals B. Program For Enhanced Review Transparency And Communication For NME NDAs And Original BLAs C. First Cycle Review Management D. Review Of Proprietary Names To Reduce Medication Errors E. Major Dispute Resolution F. Clinical Holds G. Special Protocol Question Assessment And Agreement H. Meeting Management Goals I. Enhancing Regulatory Science And Expediting Drug Development J. Enhancing Regulatory Decision Tools To Support Drug Development And Review K. Enhancement And Modernization Of The FDA Drug Safety System II. Enhancing Management of User Fee Resources A. Resource Capacity Planning And Modernized Time Reporting B. Financial Transparency And Efficiency III. Improving FDA Hiring and Retention of Review Staff A. Completion Of Modernization Of The Hiring System Infrastructure And Augmentation Of System Capacity B. Augmentation Of Hiring Staff Capacity And Capability C. Complete Establishment Of A Dedicated Function To Ensure Needed Scientific Staffing For Medical Product Review D.…”