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.
Kathleen Uhl, M.D. (remote)
Office of Generic Drugs (OGD), CDER, FDA
Highlights of Day 1: Comprehensive overviews on:
- An Overview of the draft guidance for industry: ANDA Submissions--Refuse-to-Receive Standards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
- GDUFA Regulatory Science
- Communications between FDA and Industry
- GDUFA Review Efficiency Enhancements
See agenda for more details.
For more information on CDER Small Business and Industry Assistance
workshops and webinars visit
For more information on GDUFA visit www.fda.gov/gdufa.