Safe and effective medicines for children pediatric studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act

• Corporate Author: National Research Council (U.S.)
• Other Authors: Field, Marilyn J. (Marilyn Jane) (Editor), Boat, Thomas F. (Editor)
• Format: Book
• Language: English
• Published: Washington, D.C. National Academies Press 2012
• Subjects: Clinical Trials as Topic > Congress > legislation & jurisprudence > United States; Clinical Trials as Topic > Congress > standards > United States; Adolescent > Congress > United States; Child > Congress > United States; Drug Approval > Congress > legislation & jurisprudence > United States; Drug Evaluation > Congress > legislation & jurisprudence > United States; Drug Industry > Congress > legislation & jurisprudence > United States; Infant > Congress > United States
• Online Access: Click Here to View Status and Holdings.

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 an...

Table of Contents:

• Introduction
• Children's growth and development and pediatric drug studies
• Policy framework for BPCA and PREA
• Ethical issues in pediatric drug studies
• Safety and efficacy assessment in studies conducted under BPCA and PREA
• BPCA, PREA, and drug studies with neonates
• Outcomes of written requests, requirements, studies, and labelling changes
• Pediatric studies of biologics.