Generic Drug User Fee Amendments of 2012 (GDUFA) Public Meeting: September 21, 2012
The Food and Drug Administration (FDA) held the following meeting on September 21, 2012: Generic Drug User Fee Amendments of 2012: Early Implementation. On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was enacted. GDUFA, designed to speed access to safe and effective generic drugs for the public and reduce costs to industry, requires that generic drug manufacturers pay user fees to finance critical and measurable program enhancements. GDUFA also requires that generic drug facilities, sites and organizations located around the world, provide identification information annually to FDA. The topics to be discussed include FDA’s GDUFA early implementation plans as presented in two recently published draft guidance documents. FDA plans to gather the public's input on the guidance documents and early implementation efforts.
For More Information:
Please see the Federal Register Notice announcing the Meeting.
We will provide an opportunity for organizations and individuals to submit either electronic or written comments to the docket after the meeting Comments must be submitted by October 1, 2012.
Meeting Transcript (PDF - 390KB)
GDUFA Implementation Public Meeting Webinar
Mary Beth Clarke: Opening Remarks Russ Wesdyk: GDUFA Background - Agreement/Statute & Implementation Essentials Keith Webber, Ph.D.: Enhancements to Generic Drug Review
- Douglas Stearn: Self Identification Requirements
- Donal Parks, MBA, MPM: User Fees
Open Session: Public Presentations Lisa Berry, Kim Karakorn, & David Miller: Overview and Technical Walk-Through: Payment Process Monica Bali, Overview and Technical Walk-Through - Self Identification of Generic Facilities
- Mary Beth Clarke: Closing Remarks