Dermatology Drugs for Children-U.S. Food and Drug Administration Perspective.

Drug development regulation needs of the pediatric population were not addressed until later in the twentieth century. Because of legislation including the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), clinical trials and data analysis targeting the pediatric population have resulted in drug product labeling. Drug products with pediatric dermatology indications benefit from BPCA, PREA, exclusivity incentives, newer analytical methods, and Food and Drug Administration team review. Although legislation, clinical and pharmacological research, and analytical methods have evolved, problems remain. Collaborative and targeted strategies are needed to allow timely drug labeling for pediatric dermatology populations.