PUBLIC HEARING SCHEDULED TO DISCUSS NEXT PDUFA PROGRAM

With the authority for the Prescription Drug User Fee Act (PDUFA) set to expire in September 2007, the FDA has started the ball rolling on designing the next user fee program for drug products.

The agency will hold a public hearing Nov. 14 to hear stakeholder views on PDUFA and receive public feedback on the types of features that should be included in the next program. The all-day meeting will be held at the NIH's offices in Rockville, Md. The FDA is looking for public input on two questions regarding PDUFA: what is your assessment of the overall performance of the PDUFA program thus far, and what aspects of PDUFA should be retained or changed?

Parties interested in attending the meeting must send an email message to CBERTrainingSuggestions@cber.fda.gov by Oct. 31.
For more information, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2005n-0410-nm00001.pdf.