Activities to support reauthorization of the Prescription Drug User Fee Act (PDUFA) to ensure sound financial support for new drug review.COMPLETEDON TRACK1. Gather feedback on suggestions regarding reauthorization including specific suggestions for changes to the PDUFA goals, hold a public meeting and open a docket to gather written comments5/1/2010Completed5/1/20102. Analyze written comments submitted to the docket to inform stakeholder and industry discussions6/30/2010Completed6/30/20103. Meet monthly (starting in June) with representatives of patient and consumer advocacy groups to continue discussions to inform FDA on recommendations for reauthorization5/31/2011Completed5/31/20114. Conduct negotiations and reach agreement with the regulated industry on user fee program reauthorization5/31/2011Completed5/31/20115. Submit package of proposal recommendations for reauthorization for administration review and clearance6/1/2011Completed6/1/20116. To gather feedback on the proposal recommendations for reauthorization , hold a public meeting, and open a docket to gather written comments11/15/2011Completed11/15/20117. Analyze written comments submitted to the docket12/15/2011Completed12/15/20118. Transmit final package of prepared recommendations for reauthorization to Congress by January 15, 20121/15/2012Completed1/15/2012http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htmFDA-TRACK CDER Dashboard