FDA PDUFA V Review Timelines for NDAs and BLAs

As you may know, a newly renewed version of the Prescription Drug User Fee Act (PDUFA V) took effect on October 1, 2012. It is also generally understood that there was some changes in the length of the FDA review process for New Drug Applications (NDAs) and Biologics License Applications (BLAs). However there appears to be a great deal of confusion as to the specifics. So that we don't have questions and speculations EVERY time a new PDUFA action date is announced by a biotech or pharmaceutical company, here is the complete run-down of the current timelines.

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New Molecular Entity (NME) NDA and Original BLA
Priority Review: 60-day filing period plus 6-month review = 8 months from receipt date to PDUFA date
Standard Review: 60-day filing period plus 10-month review 12 months from receipt date to PDUFA date
 
Non-NME NDA
Priorty Review: 6 months from receipt date to PDUFA date
Standard Review: 10 months from receipt date to PDUFA date
 
Class 1 Resubmissions
Priority and Standard Review: 2 months from receipt date to PDUFA date
 
Class 2 Resubmissions
Priority and Standard Review: 6 months from receipt date to PDUFA date
 
Original NDA/BLA Efficacy Supplements
Priorty Review: 6 months from receipt date to PDUFA date
Standard Review: 10 months from receipt date to PDUFA date
 
Class 1 Resubmitted Efficacy Supplements
Priority and Standard Review: 2 months from receipt date to PDUFA date
 
Class 2 Resubmitted Efficacy Supplements
Priority and Standard Review: 6 months from receipt date to PDUFA date
 
Manufacturing Supplements
Prior Approval: 4 months from receipt date to PDUFA date
All other: 6 months from receipt date to PDUFA date