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CDER Builds Strong Foundation Of NMEs For 2014 As Approval Total Hits 19

Executive Summary

CDER only needs to clear nine more novel agents to top 2013 in new molecular entity and novel biologic approvals. Priority and orphan drugs make up a higher portion of CDER’s 2014 novel approvals than has been seen in recent years. “The Pink Sheet” takes stock of FDA’s performance at mid-year.

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