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Implementation of GDUFA: Progress and Expectations
Session Chair(s)
Kathleen Uhl, MD
Director, Office of Generic Drugs, CDER , FDA, United States
With the implementation of The Generic Drug User Fee Amendments (GDUFA) on October 1, 2012, new processes and expectations for both the generic industry and the FDA were also implemented. This session will discuss the progress in implementation of GDUFA.
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)
Keith J. Flanagan
Director, Office of New Drug Policy, CDER, FDA, United States
Overview of Significant GDUFA-Related Policy Changes
Robert A. Lionberger, PHD
Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA, United States
GDUFA Regulatory Science: Implementation Update
Kathleen Uhl, MD
Director, Office of Generic Drugs, CDER , FDA, United States
Overview of GDUFA: Changes and Progress
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