Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts


Author: Effective Medicines, Pediatric Studies Conducted, Best Pharmaceuticals, Pediatric Research Equity

Date: 01.01.2011

ISBN: 0309225493

Category: Uncategorized


Posted on 2012-03-10, by LionFar.

Description




Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children and the Pediatric Research Equity Acts

Editors; Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA); Institute of Medicine

NAS PRESS | 2012 | ISBN: 0309225493 9780309225496 | 351 PAGES | PDF |5.6 MB

The report was constructed to transmit the conclusions of studies under BPCA and PREA, as well as conclusions from these assessments that might form the basis for future steps by FDA and Congress to build on the strengths and correct some of the shortcomings of these policies or their application.

Contents
SUMMARY
1 INTRODUCTION
Study Origins and Overview
Evolution of Policies to Promote Pediatric Studies of Drugs and Biologics
Selected Definitions
2 CHILDREN’S GROWTH AND DEVELOPMENT AND PEDIATRIC DRUG STUDIES
The Case of Chloramphenicol
Developmental Pharmacology and Pharmacogenomics
Tailoring Pediatric Research to Developmental Variability
Short-Term Studies and Long-Term Concerns
3 POLICY FRAMEWORK FOR BPCA AND PREA
Basic Regulatory Framework for Drug Development, Approval, and Surveillance
Best Pharmaceuticals for Children Act
Pediatric Research Equity Act
FDA Administration of BPCA and PREA
Public Access to Information
4 ETHICAL ISSUES IN PEDIATRIC DRUG STUDIES
Regulatory Requirements for Protection of Human Research Participants
FDA Organizational Resources to Support Ethical Standards in Pediatric Research
Ethical Issues in Studies Conducted Under BPCA and PREA
5 SAFETY AND EFFICACY ASSESSMENTS IN STUDIES CONDUCTED UNDER BPCA AND PREA
Sources of Information About Safety and Efficacy Results in Pediatric Drug Studies
Assessing and Monitoring Safety in Pediatric Drug Studies: Selected Issues
Assessing Efficacy in Pediatric Drug Studies: Selected Issues
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
Addendum: Labeling Changes Based on Neonate Studies Requested Under BPCA or
Required Under PREA, July1998 Through December 2010
7 OUTCOMES OF WRITTEN REQUESTS, REQUIREMENTS, STUDIES, AND LABELING CHANGES
Written Requests and PREA Requirements
Pediatric Drug Studies and FDA Reviews
Pediatric Studies and Changes in Labeling
8 PEDIATRIC STUDIES OF BIOLOGICS
Ensuring Pediatric Studies of Biologics
Identifying Biologics Not Studied with Children
Conclusions
REFERENCES
APPENDIXES
A Study Activities, Methods, and Public Meetings
B Dissemination of Information from Pediatric Studies Conducted Under BPCA and PREA
C Biologics in Pediatrics
D Biologics Studied and Not Studied in Children
E Written Requests for Studies of Pediatric Hypertension: Longitudinal Changes in FDA Specifications
F Committee and Staff Biographies

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