viernes, 21 de febrero de 2014

CDER SBIA Update: Announcing the 2014 GDUFA and You Conference - Registration Now Open

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

FDA/CDER/SBIA is announcing
the 2014 GDUFA and You Conference

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

Mark Your Calendars!! 

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.

Registration, agenda, and details are available on our website

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  • An Overview of the draft guidance for industry: ANDA Submissions--Refuse-to-Receive Standards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

For more information on GDUFA visit

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.
Please take our CDER Small Business survey:

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