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DIA 2018 Global Annual Meeting


Metrics and Meaning: Evolving Metrics in Generic Drug Application Review and Communications to Improve ANDA Submission Planning and Approvability

    Session Chair(s)
      Jason  Woo, MD, MPH

      Jason Woo, MD, MPH

      • Senior Medical Officer, Office of Generic Drugs, CDER
      • FDA, United States
    The Generic Drug User Fee Amendments of 2012 (GDUFA I) brought substantial change to the USFDA’s generic drug application (known as the abbreviated new drug application or “ANDA”) review program. GDUFA I created agency goals related to timelines for the agency completing reviews of generic drug original applications, prior approval supplements and amendments to both. These metrics helped to initiate changes and process improvements.
    The agency continues to develop an enhanced process and tracking information system, along with additional performance reports. The inclusion of more informative measures of performance of the agency and sponsors in moving applications towards approvability may provide better understanding of critical attributes and parameters in the communications between the agency and sponsors. Improving these communications will allow FDA to move ANDAs to approvability in a timelier manner.
    This session will introduce metrics and analyses FDA is developing for improving the communication of and response to critical attributes and deficiencies in original ANDA submissions and in their review and development path to approval. Presentations will describe current efforts to identify and track ANDA review attributes and communication qualities that inhibit or enhance sponsors’ effective responses to address ANDA deficiencies.
    Speaker(s)
      Representative Invited

      FDA Update

      Representative Invited

      • FDA, United States
      Jingyu (Julia)  Luan, PhD

      Abbreviated New Drug Application (ANDA) First Cycle Approvability: A GDUFA I Preliminary Report

      Jingyu (Julia) Luan, PhD

      • Deputy Division Director (Acting), OB, OTS, CDER
      • FDA, United States
      Representative Invited

      FDA Update

      Representative Invited

      • FDA, United States