Parexel unveils paper on FDA

Parexel has announced the publication of a new paper about the Food and Drug Administration (FDA), which examines regulatory processes and how alterations within them affect new drug review times and review outcomes.

The report found that that although priority-rated new drug applications (NDAs) continue to gain first-cycle approval at a higher rate than standard submissions, they fell to 50 per cent in 2008 from a record 70 per cent in 2007.

It also discovered that the FDA granted priority status to 20 per cent of NDAs submitted from fiscal 2006 to 2008, a figure down by 30 per cent from 2005.

Mark Mathieu, director of strategic research at Parexel Consulting and the study’s lead author, said: "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."

In August, Parexel posted its financial results, which revealed that its consolidated service revenue for the three months ending June 30th 2009 amounted to $247.4 million (155 million pounds).