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How Has FDARA Section 504 (RACE Act) Changed the Pediatric Oncology Landscape?
Session Chair(s)
Scott Greenfeder, PhD
Vice President, Oncology Regulatory Affairs
Bayer US LLC, United States
The implementation of FDARA Section 504 (RACE Act) requires a paradigm shift in pediatric oncology. Sharing experience and exploring potential room for improvement is essential to allow timely access to cancer treatments for children.
Learning Objective : Discuss how the RACT Act has affected pediatric oncology programs since implementation; Explore where further guidance might be helpful in pediatric oncology drug development; Discuss what else might be needed for timelier access to pediatric cancer treatments.
Speaker(s)
FDA Update
Pamela Balcazar, MS
FDA, United States
Sr. Health Scientist, Oncology Center of Excellence, OC
Industry Update
David Nguyen, PharmD, MBA
Bristol-Myers Squibb Company, United States
Associate Director, Global Regulatory Lead - Oncology
Measuring, Managing, and Moving Forward
Melodi J McNeil, MS, RPh
AbbVie, United States
Director, Regulatory Policy and Intelligence
FDA Update
Gregory Reaman, DrMed, MD
FDA, United States
Associate Director for Pediatric Oncology , OCE, OC
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