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FDA’s Banner Year for Drug Approvals: Time to Change the Focus

 
• By Michael McCaughan

FDA is entering a big legislative year with a good story to tell based on 30 new molecular entity approvals. But the level of submissions remains constant—suggesting it may be time to shift the focus from what comes out of FDA to what makes it in.

The Food & Drug Administration is putting its best foot forward heading into the Prescription Drug User Fee Act reauthorization in 2012.

The agency finished the year with 30 new molecular entity approvals. Fairly or not, the NME tally is the number...

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