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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

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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