GDUFA aims to put FDA’s generic drug program on a firm financial footing by enabling FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA’s generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications. As a direct outcome, the generic drugs program has increased patient access to safe, high-quality and affordable generic medicines. This document explains the program and how the generics industry works with FDA to improve access.
The GDUFA III Commitment Letter can be found here.