Food and Drug Administration (FDA)
Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA)
Generic Drug User Fee Amendment (GDUFA) and You Conference
March 27 - 28, 2014
WELCOME TO THE GDUFA AND YOU CONFERENCE 2014
This is a MUST ATTEND conference for anyone involved with generic drugs.
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.
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- An Overview of the draft guidance for industry: ANDA Submissions--Refuse-to-Receive Standards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 File (DMF) Basics
- DMFs with a GDUFA perspective
- Completeness Assessment for Type II API DMF under GDUFA
Highlights of Day 2: Explore aspects of:
- GDUFA Implementation Policy Updates
- User Fees / Arrears List/Appeals/Waivers
- GDUFA Regulatory Science
- Communications between FDA and Industry
- GDUFA Review Efficiency Enhancements
View the Agenda for more detailed information.
WHEN & WHERE:
|March 27 - 28, 2014|
|Hilton Orlando, Lake Buena Vista|
Contracted rate and room availability cannot be guaranteed after March 4
?THE SLEEPING ROOM BLOCK HAS BEEN SOLD OUT. VISIT THE HOTEL AND TRAVEL PAGE FOR MORE INFORMATION
|1751 Hotel Plaza Blvd
Lake Buena Vista, FL 32830
Toll Free: 1-888-370-0980
- Advance registration is required. If you need to cancel please notify Debbie@tepgevents.com
- As always with CDER SBIA conferences, registration is FREE.
- Complimentary WiFi/Internet will be available in the guest rooms and hotel common areas. Internet will NOT be available in the meeting room.
- Session and conference evaluations will be made available electronically. URL and instructions will be given during the conference.
- CEU's and CME's will not be offered at this conference.
- CONFERENCE REGISTRATION CLOSES ON MARCH 18. To register after that date please contact Debbie Levi, Debbie@tepgevents.com
- Conference Materials will be distributed on a memory stick for onsite attendees only.
*The attendee is responsible for accommodations, travel costs, meals and hotel parking.
- March 27 and 28: Optional pay on own lunch networking opportunity. Simply purchase a lunch in the hotel market or at the kiosk outside the conference room at lunch time. Join other attendees in the outdoor seating area near the conference room.
- March 27: Optional pay on own networking event from 5pm-8pm in John T's bar located in the lobby.
Note: Venue is accessible to persons with disabilities. If you have any special accommodation needs, please make requests as soon as possible to Debbie Levi at firstname.lastname@example.org.
Questions: Please contact CDER Small Business and Industry Assistance (CDER SBIA) at 1-866-405-5367 | CDERSBIA@FDA.hhs.gov