The U.S. Food and Drug Administration recently released its draft of the fifth installment of the Prescription Drug User Fee Act (PDUFA V) detailing its performance goals and procedures that would govern drug approvals from fiscal years 2013 through 2017 (October 1, 2012 - September 30, 2017). This version of the PDUFA highlights increased transparency in new drug reviews, a potential 60 day increase in review timing for such drugs, as well as an increased focus on benefit-risk.

In the report, we have included a summary of the major changes from the last version (PDUFA IV), the text of the draft document in its entirety, as well as a list of drugs potentially affected by the new legislation. The FDA and prescription drug industry must reach a final agreement on PDUFA V by September 2012.

For the full report, please download the PDF version at the top of this page.

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