PAREXEL Consulting Releases New White Paper on FDA's Drug Review Process

Today PAREXEL Consulting (Boston, MA) released its second annual study on the state of the FDA drug review process. Findings are captured in the white paper The Innovation Imperative in the Safety First Era, which answers questions such as:

  • How has the increased safety scrutiny at FDA affected new drug review times and outcome patterns?

  • If first-cycle NDA approval rates have steadied, why have approval rates for priority NDAs stumbled recently?

  • Pending NDAs surged over the last year, but have NME submissions as well?

“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," said Mark Mathieu, Director of Strategic Research at PAREXEL Consulting and the study’s lead author. "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."

That assessment also includes discussions on real-world implications of overdue NDA reviews on first-cycle approval rates and why priority-rated drugs continue to have advantages in the drug review process, despite their decline.

To find out more, the white paper is available for down load here.