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DIA 2021 Global Annual Meeting
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
- Health Scientist, Oncology Center of Excellence, OC
- FDA, United States
Industry Update
David Nguyen, PharmD, MBA
- Associate Director, Global Regulatory Lead - Oncology
- Bristol-Myers Squibb Company, United States
Measuring, Managing, and Moving Forward
Melodi J McNeil, MS, RPh
- Director, Regulatory Policy and Intelligence
- AbbVie, Inc., United States
FDA Update
Gregory Reaman, DrMed, MD
- Associate Director for Pediatric Oncology , OCE, OC
- FDA, United States