Barnett Releases New Drug Development: A Regulatory Overview

Barnett International, a division of PAREXEL International Corporation (Nasdaq:PRXL), has announced the release of New Drug Development: A Regulatory Overview, which features what is now one of the most comprehensive analyses of the drug regulatory process within the United States, the world's most lucrative pharmaceutical market.

Now in its seventh edition, New Drug Development: A Regulatory Overview is already one of the most widely read texts on the FDA's regulation, review, and approval of new pharmaceuticals. This latest edition has been updated and expanded to address the effects of pharmacogenomics and other emerging new technologies, the FDA's new good review management principles (GRMP) initiative, and the agency's emerging Pharmaceuticals cGMPs for the 21st Century initiative. The text is also the first to chronicle how a comprehensive reorganization within the Center for Drug Evaluation and Research (CDER) will affect new drug reviews going forward.

New Drug Development: A Regulatory Overview is the only text to provide an "inside" look at the FDA and its review and approval divisions, processes, and requirements. In addition, it provides a detailed analysis of U.S. preclinical and clinical testing requirements, IND and NDA submission requirements, and complete regulatory standards for modern biological products.

New Drug Development: A Regulatory Overview is available for $145 per copy by calling 800-856-2556, x2200 or by ordering online at www.barnettinternational.com.