2013 GDUFA and You Conference

For Slides from the Presentations, click here: 2013 GDUFA and You Conference Presentation SlidesGDUFA and You Conference banner

 Register Here!disclaimer icon

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:
• 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 CDER Small Business Assistance
workshops and webinars visit

For more information on GDUFA visit www.fda.gov/gdufa.

Page Last Updated: 04/11/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English