FDA holds public meeting to obtain comments on PDUFA program

FDA Holds Public Meeting on Prescription Drug User Fee Act

The U.S. Food and Drug Administration will hold a public meeting on April 12, 2010, to obtain comments on the Prescription Drug User Fee Act (PDUFA) program. The program authorizes user fees for FDA product reviews, which currently fund more than half of new drug review costs.

The meeting is scheduled for 9 a.m. to 5 p.m. at the Hilton Washington, D.C./Rockville Hotel and Executive Meeting Center in Rockville, Md.

The current legislative authority for PDUFA (PDUFA IV), reauthorized in 2007 by the FDA Amendments Act, will expire in September 2012. The FDA scheduled the meeting to gather input from stakeholders before the agency begins discussions with the regulated industry on PDUFA's reauthorization.

In preparation for the public meeting, the FDA developed a Webinar to better inform stakeholders about the PDUFA program. The Webinar provides:

• background of the program, including PDUFA's impact on public health
• a primer on drug development, and FDA's performance commitments as part of PDUFA
• an overview of FDA's experience to date in PDUFA IV.