The Pediatric Exclusivity Provision
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The first pediatric drug development incentive legislation was enacted as part of the Food and Drug Administration Modernization Act (FDAMA) in 1997. This law was commonly known as the pediatric exclusivity provision. The 2001 Status Report to Congress about the experiences under this law, as required by FDAMA, identified a number of gaps in pediatric labeling information and an inadequate focus on certain important drug categories and age groups. With the subsequent enactment of the Best Pharmaceuticals for Children Act (BPCA) in 2002, amended in 2007, and the Pediatric Research Equity Act (PREA) in 2003, amended in 2007, we have made significant progress in terms of the number, timeliness, and successful completion of studies of drugs in pediatric populations. BPCA and PREA were made permanent in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA).