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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)
Panelist
Kevin Bugin, PhD, MS, RAC
Amgen, United States
Associate Vice President, Global Regulatory Policy
Panelist
Meghana Chalasani, MHA
FDA, United States
Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER
Panelist
Michael Monteleone, MS, RAC
FDA, United States
Associate Director for Labeling, OND, CDER
Panelist
Andrew Emmett, MPH
Pfizer Inc, United States
FDA Liaison | US Regulatory Policy and Global Intelligence
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