FDA Meeting and Request for Comments on Generic Drug User Fee Program
This post was written by Paul Sheives and Areta Kupchyk.
FDA will hold a public meeting on September 17, 2010 to seek input on the development of a generic drug user fee program. Currently, FDA does not have the statutory authority to collect user fees for generic drugs. Specifically, FDA seeks comments on: (1) how the generic user fee program should differ from current user fee programs; (2) the structure of the generic user fee program; (3) performance goals for FDA; (4) whether all products should pay the same fee, or differ based on complexity of the application; (5) how to address applications currently pending review; and (6) support for post-marketing safety by generic user fees. Registration for the meeting closes September 9, 2010, but early registration is recommended. Written comments are being accepted until October 17, 2010.
