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FDA's NME Approval Rebound At Risk: Drought Of Novel Products In Line For Action In Remainder Of 2010 Could Depress Upward Trend From First Half

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Almost one-third fewer novel product applications are on FDA’s user fee calendar for the second half of 2010 as compared to the docket at the same point in 2009, a dearth that could imperil the slow but steady improvement in annual new molecular entity and novel biologic approvals after the nadirs reached earlier in the decade.

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