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Implementation of GDUFA: Progress and Expectations

Track:
Regulatory Affairs and Submissions

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
337

Room Number:
3

Level:
Intermediate

Type:
Session

Title:
Implementation of GDUFA: Progress and Expectations

Chair(s):
Kathleen Uhl, MD
Director (Acting), Office of Generic Drugs, OPS, CDER
FDA, United States

Description:
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(s):
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.

Presentation(s) & Speaker(s):
Overview of Significant GDUFA-Related Policy Changes
Keith J. Flanagan
Regulatory Counsel, Office of Generic Drugs, OPS, CDER
FDA, United States

GDUFA Regulatory Science: Implementation Update
Robert A. Lionberger
Acting Deputy Director for Science, Office of Generic Drugs, OPS, CDER
FDA, United States

Overview of GDUFA: Changes and Progress
Kathleen Uhl, MD
Director (Acting), Office of Generic Drugs, OPS, CDER
FDA, United States