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Driving Complex Generics to Approval: What are the Keys to Success
Session Chair(s)
Robert A. Lionberger, PhD
Director, Office of Research and Standards, Office of Generic Drugs, CDER
FDA, United States
GDUFA II provides new regulatory processes designed to accelerate access to generic versions of complex products. In thisforum, FDA and industry provide examples on how to effectively use these processes.
Learning Objective : Explain how the FDA review of ANDAs for complex generics has been improved under GDUFA II; Describe current regulatory and scientific considerations for generic combination products; Develop strategies to communicate more effectively with FDA during development of a complex product intended for submission under an ANDA.
Speaker(s)
Industry Perspective
Michelle Lee-Bourner, MSc
Mylan Pharma UK Ltd, United Kingdom
Head Global Respiratory and Biologics Regulatory Sciences
FDA Update
Martha Nguyen, JD
FDA, United States
Director, Division of Policy Development, OGD, CDER
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