2013 GDUFA and You Conference
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FDA’s Center for Drug Evaluation and Research
(CDER’s) Small Business Assistance hosts its first GDUFA and You conference.
What: GDUFA and You Conference
When: June 12-13, 2013
Where: Sheraton Silver Spring Hotel
8777 Georgia Avenue
Silver Spring. MD 20910
The Generic Drug User Fee Amendments of 2012 (GDUFA) is landmark drug legislation
designed to speed the delivery of safe, high-quality, and affordable generic drugs
to the public and reduce costs to industry.
We invite you to attend a conference dedicated entirely to GDUFA.
Interact with FDA subject matter experts as we discuss various regulatory elements of GDUFA.
This is a MUST ATTEND event for anyone involved with generic drugs.
On Day 1 we will present comprehensive overviews on:
• GDUFA
• User Fees and Arrears List
• Drug Master Files (DMFs)
• Compliance Notes
• DUN and Bradstreet's (D&B's) Data Universal Numbering System (DUNS) Number
• Facility Establishment Identifiers (FEIs)
On Day 2 we will explore in detail the technical aspects of:
• Electronic Submissions Gateway (ESG) and WebTrader
• Electronic Self-Identification
• Self-Identification/eSubmitter
See agenda for more details.
For more information on visit CDER Small Business Assistance
For more information on GDUFA visit www.fda.gov/gdufa.