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Advancing Generic Drug Development (AGDD): Modernizing Bioequivalence Approaches for Topical & Transdermal Products Banner

Advancing Generic Drug Development:
Modernizing Bioequivalence Approaches for 
Topical & Transdermal Products
September 10, 2026

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This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products.

FDA uses Generic Drug User Fee Amendments (GDUFA)-funded regulatory science and research to develop and revise general and product-specific guidances and to support abbreviated new drug application (ANDA) review. Case examples will show how research findings have informed guidance recommendations and ANDA assessment.

Attendees will gain practical insights into current FDA BE recommendations, alternative approaches that use modeling and simulation, characterization-based submissions, and how to determine when in vivo studies may be needed for topical and transdermal delivery systems.

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Agenda & Speaker Bios

PDF Download
Event Agenda

The event agenda is still being refined and may be updated over time. The current version is v4, uploaded on August 4, 2026.

PDF Download
Speaker Biographies

The speaker biographies document provides detailed information for each of the event presenters.  The speaker biographies document is still being refined and may be updated over time.

LOGIN Links

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

Login One

Ability to submit questions
Cannot pause or rewind
Limited to 1,000 seats
Use Login Two if this room is full

Login Two

Ability to pause or rewind
Cannot submit live questions
Unlimited Seating

Livestream Direct

Use this if you encounter issues
with the other links
Your attendance will NOT
be tracked in our system

The above rooms will open ~15 minutes before each day begins.

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

Files & Recordings

Download Presentation Slides

A link for you to download the presentation slides will be added here when they are available.

Event Evaluation & Certificate

A link for you to evaluate the Event and access the online certificate will be added here on the second afternoon of the event.

Session Recordings

Recordings will be linked here as soon as they are available.

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 September 24, 2026).

This event 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.
  • 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.

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