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PDUFA V goes back to basics

Nature Reviews Drug Discovery volume 11, pages 586–588 (2012)Cite this article

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A Corrigendum to this article was published on 03 August 2012

This article has been updated

20 years after the first PDUFA provided the FDA with additional resources, regulators and industry are refocusing on review times and approval rates.

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Figure 1: Median approval time for drug applications.
Figure 2: First-cycle approval rates.

Change history

  • 02 August 2012

    The article originally stated that under PDUFA V the agency will effectively have 10 months to review standard applications, when it will actually now have 12 months. This has been corrected online.

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  1. Asher Mullard
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Mullard, A. PDUFA V goes back to basics. Nat Rev Drug Discov 11, 586–588 (2012). https://doi.org/10.1038/nrd3819

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