Political Quotes

“I ask unanimous consent to have printed in the Record a copy of the commitment letter for the Generic Drug User Fee Act, GDUFA, reauthorization for fiscal years 2018 to 2022, known as GDUFA II. There being no objection, the material was ordered to be printed in the Record, as follows: GDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROGRAM ENHANCEMENTS FISCAL YEARS 2018-2022 I. Submission Review Performance Goals A. Original ANDAs and ANDA Amendments B. PASs and PAS Amendments C. Unsolicited ANDA and PAS Amendments D. DMFs E. Controlled Correspondence F. GDUFA I Bridging II. Original ANDA Review Program Enhancements A. ANDA Receipt B. ANDA Review Transparency and Communications Enhancements C. Review Classification Changes During the Review Cycle D. ANDA Approval and Tentative Approval E. Dispute Resolution F. Other ANDA Review Program Aspirations III. Pre-ANDA Program and Subsequent Mid-Review-Cycle Meetings for Complex Products A. Rationale for Pre-ANDA Program, Guidance on Enhanced Pathway for Complex Products B. Controlled Correspondence C. Product-Specific Guidance D. Product Development Meetings E. Pre-Submission Meetings F. Inactive Ingredient Database Enhancements G. Regulatory Science Enhancements H. Safety Determination Letters I. Other Pre-ANDA Program Aspirations IV. DMF Review Program Enhancements A. Communication of DMF Review Comments B. Teleconferences to Clarify DMF First Cycle Review Deficiencies C. DMF First Adequate Letters D.…”