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Table 1 Key landmarks in pediatric medicines regulation

From: Pharmacokinetic–Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance

Year Regulation Impact
1997 US FDA Modernization Act (FDAMA) This act presented the financial incentive of an additional 6 months of market exclusivity to companies undertaking required pediatric studies [15]
1998 US FDA Pediatric Rule This rule permitted companies to label medicines for use in children based on extrapolation of efficacy from adult trial data, together with pediatric PKPD and safety data [160]
2002 (and 2007) US Best Pharmaceutical for Children Act (BPCA) Framework for pediatric research in both on- and off-patent drugs [161]
2003 US Pediatric Research Equity Act (PREA) Sponsors required to undertake clinical studies in children for new medicines and biological products [161]
2007 EU Pediatric Regulation Introduction of new legislation in the European Union mandating pediatric medicines research for new medicinal products [16]
2012 US Food and Drug Administration Safety and Innovation Act (FDASIA) BPCA and PREA became permanent in US Law [162]
  1. PKPD pharmacokinetic/pharmacodynamic