1. Drug Master Files: New Requirements under GDUFA
This training on Generic Drug User Fee Amendments of 2012 will discuss the new requirements
under GDUFA and effect of GDUFA on the Drug Master Files (DMF) process.
Why Should You Attend:
The Generic Drug User Fee Amendments of 2012 (GDUFA) enables FDA to assess user fees and
bring greater predictability to the review of generic drug applications. The law requires industry
to pay user fees to supplement the costs of reviewing generic drug applications and inspecting
facilities. Additional resources enable FDA to reduce a current backlog of pending applications,
cut the average time required to review generic drug applications for safety, and increase riskbased inspections. It is important to have an understanding of GDUFA and the new fees and
requirements DMF holders must fulfill in order to achieve “Available for Reference” status. Only
Abbreviated New Drug Application (ANDA) submissions which reference “Available for
Reference” API DMFs can be received by FDA. Not having clarity on the new fees and
requirements could cost your organization time, money, and other critical resources.
Upon completion of this session, attendees will have a better understanding of GDUFA, its
implications regarding DMFs, who in industry is impacted, the required fees, and achieving DMF
“Available for Reference” status.
Learning Objectives:
Attain clarity on GDUFA and its implications regarding DMFs.
Gain a much better understanding of who in industry is impacted and any associated
fees.
Know what is required to achieve DMF “Available for Reference” status.
Areas Covered in the Webinar:
GDUFA background
Key definitions
Who in industry is impacted
Self-identification and fee requirements
New DMF correspondences and meetings
Completeness assessments
“Available for Reference” status
Who Will Benefit:
This webinar will provide valuable assistance to:

2. Regulatory Affairs Professionals
Project Managers
QA & QC Managers
API Manufacturers
Generic Drug Manufacturers
Type II (API) DMF Holders
ANDA Sponsors
Consultants
Any individuals interested in the generic drug industry
For more details visit us at:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~produc
t_id=703209?channel=Doc_organic