Safe and Effective Medicines for Children

Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

Author: Boat, Thomas F.; Field, Marilyn J.
Publisher: National Academies Press
ISBN: 9780309225496
eISBN Pdf: 9780309225502
Place of publication: United States
Year of digital publication: 2012
Month: September
Pages: 433
Language: English

Caption

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

Cover
Front Matter
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