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FDA Generic Drugs Forum (GDF) 2023
Celebrating 10 Years of the GDF
April 12-13, 2023

The Generic Drugs Forum 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.

Click Here for Workshop Details

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Agenda & Speaker Bios

PDF Download
Event Agenda

The agenda is still being refined and may be updated over time. The current version is v3, uploaded on March 3, 2023.

PDF Download
Speaker Biographies

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

LOGIN Information

The links below will become active on the day of the webinar.

Room One

Ability to submit questions, but cannot pause or rewind
1,000 seats – Use Room Two if this room is full

Room Two

Ability to pause or rewind, but cannot submit questions, download slides below
Unlimited Seating

The above rooms will open ~15 minutes before the webinar begins.

If you encounter any technical issues, visit the Technical Issues Support Page

The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.

To test your PC, please visit:

https://concerted.adobeconnect.com/common/help/en/support/meeting_test.htm

Files & Recordings

Download Presentation Slides:

ZIP of the Session Slides

The link above will become active on the day before the workshop.


Session Recordings:

The recordings of the Forum sessions will be linked here as soon as they are available.

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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 27, 2023).

This workshop 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.

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: