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.
Table of Contents
|2 Children's Growth and Development and Pediatric Drug Studies||43-62|
|3 Policy Framework for BPCA and PREA||63-88|
|4 Ethical Issues in Pediatric Drug Studies||89-110|
|5 Safety and Efficacy Assessments in Studies Conducted Under BPCA and PREA||111-140|
|6 BPCA, PREA, and Drug Studies with Neonates||141-176|
|7 Outcomes of Written Requests, Requirements, Studies, and Labeling Changes||177-206|
|8 Pediatric Studies of Biologics||207-230|
|Appendix A: Study Activities, Methods, and Public Meetings||261-270|
|Appendix B: Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA||271-284|
|Appendix C: Biologics in Pediatrics||285-320|
|Appendix D: Biologics Studied and Not Studied in Children||321-380|
|Appendix E: Written Requests for Studies of Pediatric Hypertension: Longitudinal Changes in FDA Specifications||381-386|
|Appendix F: Committee and Staff Biographies||387-394|
The National Academies Press (NAP) has partnered with Copyright Clearance Center's Rightslink service to offer you a variety of options for reusing NAP content. Through Rightslink, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Rightslink allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Rightslink you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the National Academies Press (NAP) through Rightslink:
Click here to obtain permission for the above reuses. If you have questions or comments concerning the Rightslink service, please contact:
Rightslink Customer Care
Tel (toll free): 877/622-5543
To request permission to distribute a PDF, please contact our Customer Service Department at 800-624-6242 for pricing.
To request permission to translate a book published by the National Academies Press or its imprint, the Joseph Henry Press, please click here to view more information.