Drugs

2014 GDUFA and You Conference

For Slides from the Presentations, click here: 2014 GDUFA and You Conference Presentation Slides

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FDA’s Center for Drug Evaluation and Research
(CDER’s) Small Business and Industry Assistance (CDER SBIA)

WELCOME TO THE GDUFA AND YOU CONFERENCE

What: GENERIC DRUG USER FEE AMENDMENT (GDUFA) and You Conference
When: March 27-28, 2014
Where: Hilton Orlando, Lake Buena Vista
1751 Hotel Plaza Blvd
Lake Buena Vista, FL 32830

This is a MUST ATTEND event for anyone involved with generic drugs
This event is FREE!

 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. This is your opportunity to interact with FDA subject matter experts as we discuss various regulatory elements of generic drugs.

Keynote Speaker:
Kathleen Uhl, M.D. (remote)
Acting Director
Office of Generic Drugs (OGD), CDER, FDA

Highlights of Day 1: Comprehensive overviews on:

  • GDUFA
  • An Overview of the draft guidance for industry: ANDA Submissions--Refuse-to-Receive Standards
  • A Filing Reviewer’s Perspective on Electronically Submitted Documents
  • Drug Master Files (DMF) Basics
  • DMFs with a GDUFA perspective
  • Completeness Assessment for Type II API DMFs under GDUFA
 
Highlights of Day 2: Generic Drugs:
  • GDUFA Implementation Policy Updates
  • User Fees / Arrears List/Appeals/Waivers
  • Inspections
  • GDUFA Regulatory Science
  • Communications between FDA and Industry
  • GDUFA Review Efficiency Enhancements

See agenda disclaimer icon for more details.

 

For more information on CDER Small Business and Industry Assistance
workshops and webinars visit
www.fda.gov/cdersbia

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

Page Last Updated: 12/12/2014
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