Political Quotes

“I ask unanimous consent to have printed in the Record a copy of the commitment letter for the Biosimilar User Fee Act, BsUFA, reauthorization for fiscal years 2018 to 2022, known as BsUFA II. There being no objection, the material was ordered to be printed in the Record, as follows: Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022 I. Ensuring the Effectiveness of the Biosimilar Biological Product Review Program A. Review Performance Goals B. Program for Enhanced Review Transparency and Communication for Original 351(k) BLAs C. First Cycle Review Management for Supplements with Clinical Data D. Guidance E. Review of Proprietary Names to Reduce Medication Errors F. Major Dispute Resolution G. Clinical Holds H. Special Protocol Question Assessment and Agreement I. Meeting Management Goals II. Advancing Development of Biosimilar Biological Products Through Further Clarification of the 351(k) Regulatory Pathway III. Enhancing Capacity for Biosimilar Regulations and Guidance Development, Reviewer Training, and Timely Communication IV. Enhancing Management of User Fee Resources A. Resource Capacity Planning and Modernized Time Reporting B. Financial Transparency and Efficiency C. Management of Carryover Balance V. Improving FDA Hiring and Retention of Review Staff A. Completion of Modernization of the Hiring System Infrastructure and Augmentation of System Capacity B.…”