The Generic Drug User Fee Amendments of 2012 (GDUFA) were designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry. A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. This webinar will discuss the effect of GDUFA on the DMF process.
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 risk-based 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 with reference to “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.
This webinar will help you 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.
Areas Covered in the Session :
Generic Drug User Fee Amendments: Background
Who in industry is impacted
Self-identification and fee requirements
New DMF correspondences and meetings
“Available for Reference” status
Who Will Benefit:
Regulatory Affairs Teams
QA & QC Managers
Generic drug manufacturers
Type II (API) DMF holders
Any individuals interested in the generic drug industry