CDER SBIA Update: 2014 GDUFA and You Conference – Don’t Forget to Register!

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry

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What: GDUFA and You Conference
When: March 27-28, 2014
Where: Orlando, FL

Are you involved with generic drugs?

Do you have questions about GDUFA?

Would you like 1:1 interaction with the FDA GDUFA experts?

Then Register Now! 

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. 

Registration, agenda, and details are available on our website 

Highlights of Day 1: Comprehensive overviews on:  

• GDUFA Update 
• An Overview of the draft guidance for industry: ANDA Submissions--Refuse-to-Receive Standards 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

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

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

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The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

• Email: CDERSBIA@fda.hhs.gov
• Phone: 1-866-405-5367
• Phone: (301) 796-6707
• Website: http://www.fda.gov/cdersbia