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The Reauthorization of GDUFA and Its Impact on Sponsor and Regulator
Session Chair(s)
Linda Bowen, MSC, RAC
Adjunct Professor, Temple University Pharmacy School, 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
Director, Office of Research and Standards, Office of Generic Drugs, CDER, FDA, United States
GDUFA II and Regulatory Science Initiatives: Pre-ANDA Program for Complex Generic Drugs
Associate Vice President, Regultory CMC, Organon, United States
Industry Perspective
Sr. Dir. Rx Regulatory Affairs, Perrigo Company plc, United States
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