What Regulatory Pathways Facilitate Pediatric Drug Development?
Several regulatory pathways exist to encourage and facilitate pediatric drug development:
- Best Pharmaceuticals for Children Act (BPCA): In the United States, this act provides incentives for pharmaceutical companies to conduct pediatric studies. - Pediatric Research Equity Act (PREA): This act requires that new drug applications include a pediatric assessment unless waived or deferred. - Paediatric Investigation Plans (PIPs): In Europe, PIPs are required for all new drug applications to ensure that necessary data are collected in children.
