Generic Drug User Fee Amendments of 2012
The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.
GDUFA is designed to build on the success of the Prescription Drug User Fee Act (PDUFA). Over the past 20 years, PDUFA has ensured a more predictable, consistent, and streamlined premarket program for industry and helped speed access to new, safe and effective prescription drugs for patients. GDUFA will also enhance global supply chain safety by requiring that generic drug facilities and sites around the world self-identify.
FY 2014 Regulatory Science Initiatives Part 15 Public Meeting FY2013 GDUFA Performance Report
This performance report covers the period of October 1, 2012, through September 30, 2013, and presents FDA’s accomplishments for the first year of GDUFA and expectations for the future
Improving the Quality of ANDA Submissions
GDUFA Information Technology Plan (Draft) FY 2013 - FY 2017(PDF - 288KB)
Self-Identification of Generic Drug Facilities, Sites and Organizations
Fiscal year 2014 reporting period for self-identification closed June 1, 2013
- Self-Identified Generic Drug Facilities, Sites and Organizations
Frequently Asked Questions
- FY 2014: Self-Identified Generic Drug Facilities, Sites and Organizations List (XLS - 1.7MB)
FY 2013: Self-Identified Generic Drug Facilities, Sites and Organizations List(XLS - 2.7MB)
- Technical Walk-Through and Live Question and Answer Session
11/19/2012 and 11/20/2012
- Overview and Technical Walk-Through of Self-Identification Process