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Generic Drug Town Hall
Session Chair(s)
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)
Panelist
Maryll Toufanian, JD
FDA, United States
Director, FDA Office of Generic Drug Policy, OGD, CDER
Panelist
Robert A. Lionberger, PhD
FDA, United States
Director, Office of Research and Standards, Office of Generic Drugs, CDER
Panelist
Susan Rosencrance, PhD
FDA, United States
Acting Director, Office of Generic Drugs, CDER
Panelist
Ashley Boam, MS
FDA, United States
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Panelist
Alonza Cruse
FDA, United States
Director, Office of Pharmaceutical Quality Operations, ORA, OGROP
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