For NME Approvals, 2008 Looks A Lot Like 2007 At Mid-Year; Will Changes At FDA Turn The Tide?
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
So far, the approval trends for new molecular entities and novel biologics in the first half of 2008 suggest that this year’s final tally may look very similar to last year’s record-low approval total.
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FDA First Cycle Approval Rate Is Silver Lining In Cloud Of Dismal NME Count
Three-quarters of the new molecular entities cleared by FDA in 2007 were approved on the first review cycle, a high for this decade and a positive note to counterbalance the record low number of NMEs approved.