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Recent Evolution of the Accelerated Approval Pathway: Impacts on Use and Implementation
Session Chair(s)
Danielle Friend Economo, PHD
Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson, United States
Thought leaders will be brought together in a fireside chat to discuss impacts observed due to recent changes to Accelerated Approval as well as current trends in how the pathway is being used and implemented.
Learning Objective : Identify the changes to Accelerated Approval resulting from the passage of FDORA; Describe the benefits and challenges encountered by regulators, industry, and patient organizations when it comes to the use of Accelerated Approval; Discuss the impacts of the changes to the Accelerated Approval pathway and how it is currently being implemented.
Speaker(s)
Industry Update
Head, Global Regulatory Policy, MSD, United States
FDA Update
Senior Vice President, Molecule Discovery and Head of Infectious Disease, Eli Lilly and Company, United States
Academic Update
Chief Medical and Scientific Officer, National Organization for Rare Disorders (NORD), United States
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