[...]... conducted under BPCA and PREA and has thereby enhanced the value of these studies Limitations still exist, however, particularly for older pediatric studies and labeling changes Copyright © National Academy of Sciences All rights reserved Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts S-6 SAFE AND EFFECTIVE. .. Academy of Sciences All rights reserved Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts S-12 SAFE AND EFFECTIVE MEDINES FOR CHILDREN led to the submission of pediatric studies for which exclusivity was granted, and more such studies will be submitted in the future The number of written requests issued... All rights reserved Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts 1 Introduction In the late 1990s, the federal government enacted policies to expand the study of drugs in children and thereby to begin to correct a serious deficit in the data on drug safety and efficacy for young patients In... be safe and effective for their medical conditions Thomas F Boat, Chair Committee on Pediatric Studies Conducted Under BPCA and PREA xi Copyright © National Academy of Sciences All rights reserved Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts Contents SUMMARY 1 INTRODUCTION Study Origins and. .. Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts SUMMARY S-3 In the late 1990s, the federal government took steps to increase the study of drugs in children and thereby reduce a serious deficit in the data on drug safety and efficacy for young patients One step was to offer economic incentives for. .. typically tailors the Copyright © National Academy of Sciences All rights reserved Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts S-4 SAFE AND EFFECTIVE MEDINES FOR CHILDREN specification of included age groups to the characteristics of the condition and drug to be studied STUDY ORIGINS AND FOCUS Consistent... of Sciences All rights reserved Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts S-14 SAFE AND EFFECTIVE MEDINES FOR CHILDREN phase studies of specific biologics or studies of biologics for treatment of conditions that are now recognized to occur more frequently in children than previously thought... study information from labeling FDA has taken steps to address many of these problems Copyright © National Academy of Sciences All rights reserved Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts S-2 SAFE AND EFFECTIVE MEDINES FOR CHILDREN  More timely planning, initiation, and completion of pediatric. .. rights reserved Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts Boxes, Figures, and Tables BOXES 1-1 1-2 Knowledge Contributed by Pediatric Drug Studies Conducted Under BPCA and PREA Types of Clinical Trials 3-1 Basic Elements of a Written Request 4-1 Determinations of Research Risks and Potential... Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts 6 BPCA, PREA, AND DRUG STUDY OF DRUGS WITH NEONATES Medication Testing and Medication Use with Neonates Drugs Studies with Neonates Conducted Under BPCA and PREA BPCA, NIH, and Studies with Neonates Conclusions Addendum: Labeling Changes Based on Neonate Studies . Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts . Safe and Effective Medicines for Children: Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act