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Session Chair(s)
Kathleen Uhl, MD
Director, Office of Generic Drugs, CDER
FDA, United States
Learning Objective : Describe the changes in the abbreviated new drug application (ANDA) review process that have been made; Describe the the communication and submission expections for ANDA applications associated with GDUFA.
Speaker(s)
Overview of Significant GDUFA-Related Policy Changes
Keith J. Flanagan
FDA, United States
Director, Office of New Drug Policy, CDER
GDUFA Regulatory Science: Implementation Update
Robert A. Lionberger, PHD
FDA, United States
Director, Office of Research and Standards, Office of Generic Drugs, CDER
Overview of GDUFA: Changes and Progress
Kathleen Uhl, MD
FDA, United States
Director, Office of Generic Drugs, CDER
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