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Last Updated: October 3, 2026
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Kris André, Associate Director for Regulatory Affairs in CDER OGD's Office of Research and Standards (ORS), and Katherine ... This presentation will cover one of the generic drug review enhancements added as part of the Generic Drug User Fee ... In this webinar, FDA provided an overview of the types of In this presentation Vince Sansone will discuss the performance goal dates associated with the reauthorization of the Generic ... On August 18, 2017, the president signed Caliope Sarago, Office of Research and Standards, discusses an overview of the Erin Skoda will discuss the new features of Callie Cappel-Lynch from CDER's Office of New Drugs discusses processes, requirements, and best practices for PDUFA ... This presentation is designed to show how the new goal structure, review classification process, information requests, discipline ...
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