The Best Pharmaceuticals for Children Act and Pediatric Research Equity Act reach the age of majority—An oncology perspective. Issue 3 (31st December 2020)

• Record Type: Journal Article
• Authors: Bernhardt, M. Brooke; Lindsay, Holly; Allen‐Rhoades, Wendy; Foster, Jennifer H.
• Is Part Of: Pediatric blood & cancer. Volume 68:Issue 3(2021)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-12-31
• Subjects: Best Pharmaceuticals for Children Act -- drug labeling -- PediatricResearch Equity Act -- research; Tumors in children -- Periodicals; Blood -- Diseases -- Periodicals; Cancer in children -- Periodicals; 618.92
• DOI: 10.1002/pbc.28871
• Languages: English
• ISSNs: 1545-5009

Abstract

Abstract: The scarcity of adequate pediatric drug labeling information has long been problematic in the pediatric population, which may place children at risk for adverse drug effects. The ontogeny of infants, children, and adolescents over the course of the first two decades of life pose complex pharmacokinetic, dosing, administration, effectiveness, and toxicity‐related questions that require specific investigation. Here, we review the history that led to the passage of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), and provide commentary on issues relevant to pediatric oncology now and in the future.