New Drug Development : A Regulatory Overview

New Drug Development: A Regulatory Overview by Mark P. Mathieu is a comprehensive resource published by Parexel International Corporation in 1997. This sixth edition spans 358 pages and is presented in English, offering insights into the regulatory landscape surrounding drug development in the United States.

Readers will find a detailed examination of the processes and laws governing the pharmaceutical industry, particularly focusing on the role of the United States Food and Drug Administration. The book addresses critical aspects of drug law and legislation, providing a thorough understanding of the regulatory framework that shapes drug development practices. This edition serves as a valuable reference for those interested in the intersection of pharmaceuticals and regulatory compliance.