Pediatric considerations

Developing medicines for children requires specific, tailored approaches to clinical trial recruitment and conduct, study design, and assessing outcomes. The FDA has issued two draft guidances for industry to assist in developing drug products to comply with the pediatric study requirements under the Pediatric Research Equity Act (PREA) and to describe the process for qualifying for pediatric exclusivity and the protections that pediatric exclusivity offers under the Best Pharmaceuticals for Children Act (BPCA). In 2022, the FDA issued a draft guidance regarding pediatric clinical trial considerations, which emphasized identifying the appropriate pediatric population to study.

Course: REG210