Generic Drug User Fee Amendments of 2012 (GDUFA) Public Meeting: September 21, 2012

The Food and Drug Administration (FDA) is announcing the following meeting: 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 The topics to be discussed include FDA’s GDUFA early implementation plans as presented in two recently published draft guidance documents.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. 

Date:  
September 21, 2012 

Time: 
9:00 a.m.  - 1:00 p.m.

Location: 
FDA White Oak Campus (see campus information)
10903 New Hampshire Ave.
Bldg. 2, Room 2047
Silver Spring, MD 20993

Attendees:

If you wish to attend and/or present at the meeting, please email your registration information to GDUFA_Meeting@fda.hhs.gov by September 14, 2012. Your email should contain complete contact information for each attendee, including name, title, affiliation, address, email address, and telephone number. Registration is free and will be on a first-come, first-served basis. Early registration is recommended because seating is limited. FDA may limit the number of participants from each organization as well as the total number of participants, based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. We will try to accommodate all persons who wish to make a presentation. The time allotted for presentations may depend on the number of persons who wish to speak. In general, the meeting format will include a presentation by FDA and presentations by stakeholders and members of the public who have registered in advance to present at the meeting. The amount of time available for presentations will be determined by the number of people who register to make a presentation.

For those unable to attend in person, FDA will Web cast and provide a telephone audio link to the meeting. 

To join the Web meeting, please go to:
http://fda.yorkcast.com/webcast/Viewer/?peid=5d604f8fb5db4f1b9f0190db50a420611d.
The dial in (listen only) is: 877-231-0558 / passcode: 964287

If you have never attended a Connect Pro meeting before, you may wish to test your connection by going to: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.

Comments: 

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. 

For More Information:

Please see the Federal Register Notice announcing the Meeting.