Pediatric Drug Development

Pediatric drug development is crucial for creating safe and effective medications tailored to children’s and adolescent’s healthcare needs. It involves careful research and collaboration among researchers, healthcare professionals, and pharmaceutical companies. The American Academy of Pediatrics supports the development of pediatric drugs by providing guidance, advocating for pediatric research, and collaborating with stakeholders to ensure that medications are tailored to children’s needs, promoting their safety and efficacy in pediatric healthcare.

Learn more about two laws, the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA).

Pediatric Research Equity Act (PREA)

PREA gives the Food and Drug Administration (FDA) the authority to require pediatric studies in the development of drugs and biological products. Studies must use appropriate formulations and dosing for each age group.  The goal is obtaining pediatric labeling for a product as safe and effective for use for specific indications in children and adolescents.

Best Pharmaceuticals for Children Act (BPCA)

BPCA is a US federal law that encourages and facilitates pediatric drug testing and research by providing incentives to pharmaceutical companies. BPCA aims to improve the safety and efficacy of medications used in children by promoting clinical studies and labeling enhancements specifically for pediatric use.

Both of these laws play crucial roles in advancing pediatric drug development.