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FDA Generic Drugs Forum 2024

Generic Drugs Forum (GDF) 2024:
Regulatory Considerations to Enhance Generic Drug Access
April 10-11, 2024

The Generic Drugs Forum is an annual, two-day 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.

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Agenda & Speaker Bios

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Event Agenda

The agenda is still being refined and may be updated over time. The current version is v5, uploaded on April 2, 2024.

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Speaker Biographies

The speaker biographies document provides detailed information for each of the event presenters.



Files & Recordings

Download Presentation Slides:


Session Recordings:

Questions & More Information

Continuing Education:

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 (until April 25, 2024).

This event has been pre-approved for:

  • a maximum of 13.25 contact hours of continuing education for physicians, pharmacists, and nurses. Each day after the course concludes, that day’s attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via the two rooms linked above will receive the claim codes.
  • 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.
  • 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.
  • 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.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.

More Information

If you have questions regarding the content of the event or other CDER-specific information, please: