FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective
CRS Report, FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, May 1, 2007. “The Best Pharmaceuticals for Children Act (BPCA, P.L. 107-109) and the Pediatric Research Equity Act (PREA, P.L. 108-155) allow the Food and Drug Administration (FDA) to offer financial and regulatory incentives to manufacturers for testing their products …