Stats show weakness in Q4 NDAs

For drug applications, third-quarter submissions appear to fare far better than those made in Q4.

Employee-compensation incentives may be driving the "sloppier" fourth-quarter applications, say presenters at the Regulatory Affairs Professionals Society conference in Philadelphia, which tend to include a higher rate of errors and omissions in clinical data leading to FDA questions and delays.

An analysis of first-cycle reviews by consultancy Booz Allen Hamilton shows that of fourth-quarter applications from 2002 to 2007, only 38 percent were approved, compared with a 70 percent first-cycle approval rate for third-quarter applications. Nearly half of all applications made in those years came in the final quarter, according to a Dow Jones report.

An FDA official at the conference advises "letting internal corporate deadlines slide if an application isn't ready for prime time."

- here's the report [1]

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2007 FDA approvals [3]
2008 NME approvals no better than last year? [4]
Dry spell or parched desert for NME approvals? [5]