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Last Updated: October 3, 2026
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Caliope Sarago, Office of Research and Standards, discusses an overview of the Karen Bengtson from the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD) and Suneela Prodduturi ... Fang Yuan, PhD, Office of Lifecycle Drug Products, discusses GDUFA-II Kris André, Associate Director for Regulatory Affairs in CDER OGD's Office of Research and Standards (ORS), and Katherine ... Lei Zhang from the Office of Generic Drugs provides an overview of the This presentation provided an overview of the Kris Andre from CDER's Office of Generic Drugs shares how to interact with FDA prior to submission on complex products. Callie Cappel-Lynch from CDER's Office of New Drugs discusses processes, requirements, and best practices for PDUFA ... Ted Sherwood from the Office of Generic Drugs (OGD) discusses the In this presentation, Robert Lionberger will discuss the GDUFA II This presentation described the purpose and scope of This session offered a quality reviewer's perspective on
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