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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)
Pamela Balcazar, MS
Sr. Health Scientist, Oncology Center of Excellence, OC, FDA, United States
FDA Update
David Nguyen, PHARMD, MBA
Associate Director, Global Regulatory Lead - Oncology, Bristol-Myers Squibb Company, United States
Industry Update
Melodi J McNeil, MS, RPH
Director, Regulatory Affairs (Global Regulatory Lead, Oncology Early Development, AbbVie, United States
Measuring, Managing, and Moving Forward
Gregory Reaman, DrMed, MD
Associate Director for Pediatric Oncology , OCE, OC, FDA, United States
FDA Update
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