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Few, But Fast And On Time: 2010 Saw Low NMEs, But Almost All Were First-Cycle Approvals And FDA Met Most User Fees

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The rate of first-cycle approvals of new molecular entities in 2010 eclipsed previous highs, suggesting that the regulatory innovations of the FDA Amendments Act are paying off in terms of review efficiency.
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