One Year Anniversary of PDUFA V

Conversations: PDUFA V

09.30.13 | By Matt Bennett

In 1992, under the Prescription Drug User Fee Act (PDUFA), the U.S. Food and Drug Administration (FDA) began collecting fees from biopharmaceutical companies to provide much needed resources to keep new medicines moving through the approval process and into the hands of patients. 

Before PDUFA was enacted, it often took FDA more than two years to review applications for new medicines. However, the PDUFA fees have served as an important funding source for the FDA infrastructure, and today, allow for more efficient approvals. In fact, in the last 20 years, PDUFA has helped expedite the approval process for more than 1,500 new drugs and biologics by  decreasing review times for these treatments by more than 60 percent.

Now in its fourth reauthorization, the implementation of PDUFA V marks its one-year anniversary today, October 1, 2013. So, for Conversations this week, we wanted to know:

On the one-year anniversary of the implementation of the Prescription Drug User Fee Act (PDUFA V), what element has shown the most promise? 

We look forward to our contributors sharing their thoughts, and encourage you to join the conversation in the comment section after the post.

 

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