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  4. Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations - 06/11/2026
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Webcast | Virtual

Event Title
Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations
June 11, 2026

Date:
June 11, 2026
Time:
8:30 a.m. - 12:30 p.m. ET

Agenda

This is a NO COST event 
Attend virtually via Adobe Connect

Register Here

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About this Event (Hosted by CDER SBIA)

The field of patient-specialized oral drug formulations continues to evolve, presenting unique bioequivalence (BE) challenges that require innovative regulatory approaches. This workshop is designed to facilitate discussions about the latest advancements and regulatory considerations in the evolving field of patient-centric (including pediatric) generic oral products, addressing product development and regulatory assessment challenges for these important medicines.

Attendees will gain valuable insights into the intricacies of developing generic versions of specialized oral formulations across diverse areas. The scope of discussions will include chewable tablets, orally disintegrating tablets, pellet/granule formulations, suspension products, and sublingual/buccal formulations. This workshop will also address challenges for the development and assessment of generic pediatric-specific formulations designed to meet the unique needs of patient populations with swallowability challenges.

Through a series of expert-led presentations and Q&A sessions, participants will have the opportunity to hear from and pose questions to experts from FDA, to help deepen their understanding of current best practices, challenges and opportunities, regulatory expectations, and emerging trends. Specifically, the workshop will cover critical areas such as regulatory strategies for patient-centric formulations, formulation-specific development issues, regulatory strategies for pediatric formulations, and innovative BE approaches including physiologically based pharmacokinetic (PBPK) modeling to support generic pediatric product development. These topics reflect some of the most challenging issues facing patient-centric oral generic drug development, and the workshop will facilitate a discussion of the scientific and regulatory innovations being deployed to overcome these challenges.

Don't miss this unique opportunity to learn how to improve your generic drug development!

Intended Audience

Scientists, researchers, current and prospective generic drug applicants, and regulatory affairs professionals who work on or have an interest in the development of oral generic drugs.

Topics Covered

  • Common regulatory challenges of patient-centric oral formulations
  • Up-to-date formulation-specific regulatory strategies and best practices to support the product development and BE evaluation (including feeding tube studies and BE study dose selection) of various patient-centric oral formulations, including chewable tablets, pellets/granules, sublingual/buccal products, orally disintegrating tablets, and suspensions.
  • Known issues and practical strategies for the development of generic oral pediatric formulations

Learning Objectives

  • Stay up to date with the latest advancements in science, research, FDA guidance recommendations, and regulatory perspectives related to relevant oral generic drug products
  • Recognize and explain how the FDA's GDUFA-funded research can be leveraged to support and inform generic drug development
  • Learn how to utilize various strategies and methodologies to facilitate efficient generic drug development

Continuing Education (CE)

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 course 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.

Resources

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