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The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator
Session Chair(s)
Linda Bowen, MSc, RAC
Chief of Staff, Oncology Regulatory Strategy
Pfizer Inc, United States
GDUFA II creates a new program to support development of complex generic products including development meetings, pre-filing meetings and mid-cycle communications. This session will look at the details of the draft commitment letter and the future environment for complex generics.
Learning Objective : Discuss what’s new in GDUFA II and the impact on sponsors and regulators.
Speaker(s)
Complex Generics: How Pre-ANDA Interactions with the Office of Generic Drugs Work
Robert A. Lionberger, PhD
FDA, United States
Director, Office of Research and Standards, Office of Generic Drugs, CDER
GDUFA II and Regulatory Science Initiatives: Pre-ANDA Program for Complex Generic Drugs
Scott David Tomsky, MS
Organon, United States
Associate Vice President, Regultory CMC
Industry Perspective
Keith Webber, PhD
Perrigo Company plc, United States
Sr. Dir. Rx Regulatory Affairs
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