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Modernizing CDER’s New Drugs Review Program (NDRP): A Progress Update
Session Chair(s)
Yoni Tyberg, MHA
Associate Director of Special Programs, Office of New Drugs, CDER, FDA, United States
In 2017, CDER began modernizing the New Drugs Regulatory Program. This session shares progress updates and offers dialogue to enhance the program's key areas.
Learning Objective : Describe the impetus for modernizing CDER’s Drug Regulatory Program (NDRP); Identify the NDRP strategic objectives and their associated initiatives; Discuss the progress and outcomes of two NDRP workstreams: Advisory Committees and Investigational New Drugs
Speaker(s)
Kevin Bugin, MS, RAC
Head of Global Regulatory Policy and Intelligence, Amgen, United States
Panelist
Meghana Chalasani, MHA
Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States
Panelist
Michael Monteleone, MS, RAC
Associate Director for Labeling, OND, CDER , FDA, United States
Panelist
Andrew Emmett, MPH
Vice President, Global Regulatory Policy and Global Intelligence , Pfizer, United States
Panelist
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