BOSTON, Oct. 26 /PRNewswire/ — 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
a new white paper entitled Drug Innovation, Approval, Market
Access, and the “New Normal”: Emerging FDA Review Outcome Trends
for New Drugs.  Exploring trends in the review of new
molecular entities (NMEs), as well as first-cycle approval and
priority designation rates,
PAREXEL Consulting’s analysis indicates that there is a “new
normal” emerging in the
drug review and approval process.

PAREXEL Consulting’s analysis identified notable declines in
both first-cycle approval rates for priority drug applications and
priority designation rates for new drugs at the time when the U.S.
Food and Drug Administration (FDA) settled into its FDA Amendments
Act (FDAAA)-related responsibilities and the 21st Century Review
Process.  Between 2008 and 2009, for example, PAREXEL
Consulting found that there was a 25 percent decline in first-cycle
approval rates for priority-rated new drugs and a 17 percent
decrease in priority designations for new drug applications
(NDAs).

“First-cycle approval rates are a key indicator of the
biopharmaceutical industry’s success in securing FDA approval for
new therapies early in the review process.  While there is
often some fluctuation in first-cycle approval rates year-to-year,
our analysis of the latest FDA metrics leads us to ask whether
there is a ‘new normal’ emerging, which has significant
implications for the drug-review process,” said Mark Mathieu,
Director of Strategic Research at PAREXEL Consulting.

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