Drug Master Files: New Requirements under GDUFA

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 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.

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:

• 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

Instructor Profile:

Camille Davis Thornton, M.S., RAC is the founder of MACE Concepts, LLC, an independent consultancy specializing in providing innovative regulatory, compliance, and training solutions. Ms. Thornton has an M.S. in Biotechnology from The Johns Hopkins University and certifications from the Regulatory Affairs Professionals Society (RAC-US) and the National Restaurant Association (ServSafe® Food Protection Manager, Instructor, and registered Examination Proctor). Additionally, she has over 15 years of experience in multiple regulated industries and actively teaches at the college level.

Ms. Thornton areas of expertise include regulatory filings, the FDA Electronic Submissions Gateway (ESG), and liaising with government agencies. Also known as the “Perpetual Inquisitive Geek”, she regularly reviews applicable guidance documents, notifications, newsletters, blog postings, and email alerts from various government agencies to stay up-to-date with current requirements and industry trends. She is a regulatory affairs professional and trainer with a true passion for sharing knowledge effectively.

Topic Background:

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.

Although a DMF submission is not required by law or FDA regulation, it is often created to permit the FDA to review information in support of a third party’s submission without revealing the contents of the file to the third party. This maintains the confidentiality of proprietary information. DMFs usually cover the Chemistry, Manufacturing and Controls (CMC) of a drug product component (e.g., drug substance). The information contained in a DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.

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