Lower Costs For Drug Review Personnel Are “Completely Normal” – FDA
This article was originally published in The Tan Sheet
While personnel costs fall in human drug reviews, non-personnel expenses increase. The changes could indicate FDA cost containment, but also come with another user fee increase.
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With 19 novel agents approved so far in 2013 and a full slate of candidates under review, the recovery in novel agent approvals after the doldrums of the 2000s is likely to continue even if the agency falls short of last year’s 45 approvals. Watch for action on the first “breakthrough” therapies submitted and advances in hepatitis C treatment.
Members will enter data into secure database, allowing trade groups to gauge trends and problems with the PDUFA V application review program – and giving industry a stronger negotiating position for the next user fee round.
FDA official says the rate of approving applications in the first review cycle may not increase much more, even as the new review model, intended to promote more first-cycle approvals, has yet to finish with its inaugural applications.