Pediatric study requirements are included in the Pediatric Research Equity Act (PREA), which requires biopharma companies to study their products in children under certain circumstances, and the Best Pharmaceuticals for Children Act (BPCA). The new Research to Accelerate Cures and Equity (RACE) for Children Act will expand FDA’s authority to require companies to undertake pediatric study plans pursuant to PREA.¬†(Regulatory Affairs Professionals Society)