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Regulatory Issues 

Regulatory Issues
Chapter:
Regulatory Issues
Author(s):

Thomas P. Laughren

and Mark A. Ritter

DOI:
10.1093/med/9780195398212.003.0051
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date: 20 October 2020

Chapter 51 reviews U.S. Food and Drug Administration (FDA) initiatives in recent years to stimulate drug research in the pediatric population and the impact of these initiatives on drug development in pediatric psychopharmacology, the substantial regulatory changes that have been implemented that have led to additional clinical trials being conducted in pediatric patients for psychiatric indications. The chapter also considers the assessment of safety, the balancing of science and ethics, the preschool population, and other issues that must be addressed for drug development in this area to progress, and includes a brief overview of drug development and the regulatory process. In some cases, it will be necessary to limit details of the discussion to protect the proprietary rights of individual sponsors who have drug development programs under way in this area.

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