For Industry
PDUFA Meetings
FDA periodically conducts meetings on the Prescription Drug User Fee Act (PDUFA) program. The current legislative authority for PDUFA (PDUFA IV), reauthorized in 2007 by the FDA Amendments Act (FDAAA), will expire in September 2012. FDAAA requires that FDA hold public meetings and conduct discussions with both the regulated industry and stakeholder groups in developing recommendations for the next PDUFA program (FY2013-2017).
This page contains information for both the public part of the PDUFA reauthorization process and the discussions FDA holds with industry and stakeholders.
PDUFA Public Meeting October 24, 2011
The October 24, 2011 meeting was held to discuss the proposed recommendations for the reauthorization of PDUFA.
- Prescription Drug User Fee Act; Notice of Public Meeting, October 24, 2011
Federal Register Notice (9/12/2011) Agenda, PDUFA Public Meeting, October 24, 2011 (PDF - 94KB)Transcript, PDUFA Public Meeting, October 24, 2011 (PDF - 1.6MB)- Comments Submitted to the PDUFA Public Meeting Docket (FDA-2010-N-0128)
Stakeholder Discussions on PDUFA V Reauthorization
The minutes of meetings between FDA and stakeholder groups are posted below:
- May 20, 2011 (PDF - 71KB)
- April 28, 2011 (PDF - 71KB)
- March 18, 2011 (PDF - 71KB)
- February 28, 2011 (PDF - 76KB)
- January 11, 2011 (PDF - 97KB)
- December 17, 2010 (PDF - 85KB)
- November 17, 2010 (PDF - 82KB)
- October 22, 2010 (PDF - 88KB)
September 29, 2010 (PDF - 96KB)- August 5, 2010 (PDF - 84KB)
- July 1, 2010 (PDF - 100KB)
Industry Discussions on PDUFA V Reauthorization
The minutes of meetings between FDA and the regulated industry are posted below:
- May 17, 2011 (PDF - 58KB)
- May 10, 2011 (PDF - 68KB)
- May 12, 2011 (PDF - 59KB)
- March 31, 2011 (PDF - 69KB)
- March 25 2011 (PDF - 62KB)
- March 15, 2011 (PDF - 62KB)
- March 10, 2011 (PDF - 63KB)
- February 24, 2011 (PDF - 66KB)
- February 24, 2011 (PDF - 70KB)
- February 24, 2011 (PDF - 63KB)
- February 18, 2011 (PDF - 60KB)
- February 15, 2011 (PDF - 66KB)
- February 10, 2011 (PDF - 65KB)
- February 10, 2011 (PDF - 80KB)
- February 10, 2011 (PDF - 61KB)
- February 10, 2011 (PDF - 59KB)
- February 4, 2011 (PDF - 64KB)
- January 31, 2011 (PDF - 64KB)
- January 31, 2011 (PDF - 83KB)
- January 27, 2011 (PDF - 63KB)
- January 25, 2011 (PDF - 60KB)
- January 24, 2011 (PDF - 80KB)
- January 20, 2011 (PDF - 57KB)
- January 18, 2011 (PDF - 111KB)
updated 2/25/2011 - January 10, 2011 (PDF - 236KB)
updated 3/1/2011 - January 7, 2011 (PDF - 58KB)
- January 6, 2011 (PDF - 152KB)
updated 2/25/2011 - December 13, 2010 (PDF - 225KB)
- December 6, 2010 (PDF - 81KB)
- November 22, 2010 (PDF - 76KB)
- November 18, 2010 (PDF - 61KB)
- November 4, 2010 (PDF - 57KB)
- October 25, 2010 (PDF - 65KB)
- October 12, 2010 (PDF - 81KB)
- September 27, 2010 (PDF - 86KB)
- September 13, 2010 (PDF - 81KB)
- August 9, 2010 (PDF - 118KB)
- July 1, 2010 (PDF - 65KB)
PDUFA Public Meeting April 12, 2010
The April 12, 2010, meeting was related to PDUFA V reauthorization.
Prescription Drug User Fee Act (PDUFA); Notice of Public Meeting April 12, 2010
Federal Register notice (issued 3/16/2010)Agenda, PDUFA Public Meeting, April 12, 2010 (PDF - 91KB)Transcript, PDUFA Public Meeting, April 12, 2010 (PDF - 531KB)- Comments Submitted to the PDUFA Public Meeting Docket (FDA-2010-N-0128)
Prescription Drug User Fee Act (PDUFA) Webinar
PDUFA IV Public Meetings
Information about the three major public meetings that were held for PDUFA IV
