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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.


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 : Recognize 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 to move toward improved generic application approvability, related to the FDA Commissioner’s actions to improve access to affordable medicines.
    Speaker(s)
      Maryll  Toufanian, JD

      Panelist

      Maryll Toufanian, JD

      • Acting Director, FDA Office of Generic Drug Policy
      • 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
      Susan M. Rosencrance, PhD

      Panelist

      Susan M. Rosencrance, PhD

      • Director, Office of Lifecycle Drug Products, OPQ, CDER
      • FDA, United States
      Ashley  Boam, MS

      Panelist

      Ashley Boam, MS

      • Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
      • FDA, United States
      Alonza E. Cruse

      Panelist

      Alonza E. Cruse

      • Director, (Acting) Pharmaceutical Quality Program, ORA, OGROP
      • FDA, United States