FrontMatter -- Acknowledgments -- Reviewers -- Preface -- Contents -- Boxes, Figures, and Tables -- Abbreviations and Acronyms -- Summary -- 1 Introduction -- 2 Children's Growth and Development and Pediatric Drug Studies -- 3 Policy Framework for BPCA and PREA -- 4 Ethical Issues in Pediatric Drug Studies -- 5 Safety and Efficacy Assessments in Studies Conducted Under BPCA and PREA -- 6 BPCA, PREA, and Drug Studies with Neonates -- 7 Outcomes of Written Requests, Requirements, Studies, and Labeling Changes -- 8 Pediatric Studies of Biologics -- References -- Appendix A: Study Activities, Methods, and Public Meetings -- Appendix B: Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA -- Appendix C: Biologics in Pediatrics -- Appendix D: Biologics Studied and Not Studied in Children -- Appendix E: Written Requests for Studies of Pediatric Hypertension: Longitudinal Changes in FDA Specifications -- Appendix F: Committee and Staff Biographies -- Index.