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DIA 2018 Global Annual Meeting


Generic Drug Town Hall

    Session Chair(s)
      Kathleen  Uhl, MD

      Kathleen Uhl, MD

      • Director, Office of Generic Drugs, CDER
      • FDA, United States
    This forum will include information related to the implementation, policy, and regulatory science updates related to the Generic Drug User Fee Amendments (GDUFA).
    Learning Objective : Provide an overview of and challenges inherent to implementing the Generic Drug User Fee Amendments (GDUFA); Discuss policies impacting generic drug development, regulatory review, oversight, inspections and facilities assessments; Describe an update on regulatory science initiatives for complex generic drug products; Discuss opportunities for industry toward improved generic application approvability, related to the FDA Commissioner’s actions to improve access to affordable medicines.
    Speaker(s)
      Maryll  Toufanian

      Panelist

      Maryll Toufanian

      • Regulatory Policy, OGDP, CDER
      • FDA, United States
      Robert A. Lionberger, PhD

      Panelist

      Robert A. Lionberger, PhD

      • Director, Office of Research and Standards, Office of Generic Drugs, CDER
      • FDA, United States
      Representative Invited

      Panelist

      Representative Invited

      • FDA, United States
      Representative Invited

      Panelist

      Representative Invited

      • FDA, United States
      Representative Invited

      Panelist

      Representative Invited

      • FDA, United States