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

https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-bioequivalence-challenges-patient-centric-oral-formulations?utm_medium=email&utm_source=govdelivery Join us for the Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations workshop! 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. The scope of discussions will include chewable tablets, orally disintegrating tablets, pellet/granule formulations, suspension products, and sublingual/buccal formulations, with a focus on regulatory strategies for patient-centric and pediatric formulations, formulation-specific development issues, and innovative bioequivalence approaches including physiologically based pharmacokinetic modeling to support generic pediatric product development. 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. Don't miss this unique opportunity to learn how to improve your generic drug development! https://events-na12.adobeconnect.com/content/connect/c1/1315899612/en/events/event/shared/4940910716/event_registration.html?sco-id=7010350222&_charset_=utf-8