BOSTON, Sept. 23 /PRNewswire-FirstCall/ -- PAREXEL Consulting, a business unit of PAREXEL International (Nasdaq: PRXL) and a leading global life sciences consultancy serving the biopharmaceutical and medical device industries, today released its second annual study on the state of the U.S. Food and Drug Administration (FDA) drug review process. The PAREXEL Consulting analysis, contained in the new white paper entitled "The Innovation Imperative in the Safety First Era," provides insight into how regulatory changes and marketplace dynamics are impacting new drug review times and review outcomes.
"The implications of FDAAA and CDER's* implementation of the law have been widely discussed, and there is considerable conjecture in the biopharmaceutical industry regarding how FDA review timelines and the approval process are being impacted by new requirements, such as REMS--Risk Evaluation and Mitigation Strategies. What our research provides is a real-world, metrics-based assessment to help inform expectations of new drug review outcomes in the Safety First Era," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting and the study's lead author.
The study findings link the implementation of the Food and Drug Administration Amendments Act (FDAAA), as well as FDA's workload and staffing-related challenges, to user-fee review time targets, which were not met for 17% of the Fiscal Year 2008 New Drug Applications** (NDAs), and 36% of the priority-rated NDAs. PAREXEL Consulting's analysis also indicates that although priority-rated NDAs continue to gain first-cycle approval at a higher rate than standard submissions, they dipped to 50% for the Fiscal Year 2008 cohort,** down from a record 70% in 2007. Furthermore, data indicate that FDA granted priority stat
|SOURCE PAREXEL International Corporation|
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