This post was written by Erin Janssen.
On December 19, 2011, the FDA is hosting a public meeting to discuss proposed recommendations for enactment of a Generic Drug User Fee Act (GDUFA), which would authorize FDA to collect fees and use them for the process for the review of human generic drug applications and associated Type II Active Pharmaceutical Ingredient Drug Master Files and for conducting associated inspections for fiscal years (FYs) 2013–2017. The FDA notes that new legislation would be required for FDA to establish and collect user fees under such a program. Registration for the meeting closes December 12; the meeting also will be webcast. The FDA also is accepting written is comments on the recommendations until January 6, 2012.