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  • Drug Master Files: New Requirements under GDUFA

  • Hosted By:
  • Complianceonline
  • Start:
  • Tuesday - Jan 14, 2014 10:00 AM
  • End Time:
  • Tuesday - Jan 14, 2014 11:00 AM
  • Location:
  • Online
  • 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 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
    -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.
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