Training Course Syllabus:

DMF under GDUFA - Drug Master Files: New Requirements under GDUFA Webinar

Time: 11:30 AM PST | 02:30 PM EST

Duration: 90 Minutes

Instructor: Camille Davis Thornton

Description:

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 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 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.

Why Should you Attend:

• 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.

Objectives of the Presentation:

• 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

Seminar Summary:

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 (see full course description)

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