"With continuing focus on first-cycle approvals for new drugs, especially under FDA Good Review Management Practices, our goal was to provide biopharmaceutical companies with a real-world metric on the value of first-cycle approvals," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting. "Our data show that priority designations are now closely linked to first-cycle approvals for both NMEs and NDAs. As a result, this metric can help biopharmaceutical companies assess the value of the new priority review vouchers available under the FDA Amendments Act."
The Getting to Approval white paper 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 http://www.PAREXELConsulting.com/firstcycleapproval.
About PAREXEL Consulting
PAREXEL Consulting is a leading life sciences consultancy that helps
companies design and execute their biopharmaceutical and medical device
product strategies through our unique fusion of scientific, regulatory, and
business expertise. Our approach helps clients manage risk, and drives
superior quality and performance for clients worldwide. The firm has more
than 270 experts, and serves clients on a global basis. For further
|SOURCE PAREXEL International|
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