The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
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?
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- An Overview of the draft guidance for industry: ANDA Submissions--Refuse-to-Receive Standards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
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
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