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  4. Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF - 04/12/2023
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Event Title
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF
April 12 - 13, 2023

April 12 - 13, 2023
- ET
- ET


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The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.

This year’s theme is Celebrating 10 Years of GDF and presentations will focus on hot topics such as GDUFA III updates, information and technology, and complex generics.


  • Generic Drug User Fee Amendments (GDUFA) through September 2027 (GDUFA III)
  • Product Specific Guidances
  • ANDA Submissions – Best Practices and Tips
  • Policy, Global & Complex Generics Updates
  • Information Technology Updates
  • Using Orange Book as a Resource


Jacqueline Corrigan-Curay, J.D., M.D
Principal Deputy Center Director
Center For Drug Evaluation and Research (CDER) | FDA

Iilun Murphy, M.D.
Deputy Director for Clinical and Regulatory Affairs
Office of Generic Drugs (OGD) | CDER | FDA

Sau (Larry) Lee, Ph.D.
Deputy Director of Science
Office of Pharmaceutical Quality (OPQ) | CDER | FDA


The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:

  • plan to submit an ANDA, are in the process of submitting an ANDA, or have submitted an ANDA
  • are involved in generic drug development



Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This webinar has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.


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