USA

• RACE for Children Act (LINK)
• FDARA Section 504 “RACE” Act implementation slides (LINK)
• FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs - Guidance for Industry (LINK)
• Pediatric Research Equity Act – PREA (LINK)
• Pediatric Exclusivity Under Section 505A FAQs (LINK)
• FDA International Collaboration / Pediatric Cluster (LINK)
• FDA Pediatric Science and Research Activities (LINK)
• Oncology Center of Excellence Pediatric Oncology Program (LINK)
• Template for initial Pediatric Study Plans (LINK)
• Drugs Approved for Childhood Cancers (LINK)