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U.S. Department of Health and Human Services

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The graph illustrates the approval profile of new molecular entities (NME's) approved pre-PDUFA and under PDUFA I, PDUFA II, PDUFA III, and PDUFA IV. Before the original PDUFA was enacted in 1992, 60% of new molecular entities (NME's) were approved within a 60 month period. Under PDUFA IV, review times had dropped significantly and 85% of NME's were approved in the same 60 month timeframe.

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