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PAREXEL Consulting Releases New Study Data on Drug Development Timelines in Safety First Era
Date:9/23/2009

us to 20% of NDAs submitted from fiscal 2006 to 2008, down from 30% in 2005, suggesting that this designation is increasingly difficult to obtain.

"Despite the recent decrease in first-cycle approval rates and increase in overdue reviews for priority NDAs, we believe that there remains powerful evidence in our study to support what PAREXEL Consulting calls the "The Innovation Imperative"--the concept that the most innovative new drugs stand to receive greater regulatory attention and more rapid marketing approval," said Alberto Grignolo, Ph.D., Corporate Vice President, Global Strategy Services, PAREXEL Consulting. "Our analysis shows that pursuing priority review status and submitting quality NDAs that can be approved on the first review cycle should continue to be carefully considered by pharmaceutical companies when seeking FDA approval for new drugs and earlier launch dates."

Further supporting "The Innovation Imperative" are PAREXEL's findings in regard to New Molecular Entity (NME) approvals. The PAREXEL Consulting study shows that among the NMEs approved by FDA in the first five months of 2009, priority-rated NMEs were cleared 13.3 months faster than standard-rated NMEs.

The white paper "The Innovation Imperative in the Safety First Era" is part of PAREXEL Consulting's Intelligent Development Series, which provides data and insights in support of successful biopharmaceutical and medical device product development. The white paper is available at: www.ParexelConsulting.com/innovation-imperative.

* Center for Drug Evaluation and Research (CDER), a division of FDA

** Data as of April 1, 2009

About PAREXEL Consulting

PAREXEL Consulting, a division of PAREXEL International, provides integrated product d
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SOURCE PAREXEL International Corporation
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