FDA/Center for Research on Complex Generics (CRCG) Workshop on Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products May 5 - 6, 2026

Workshop | Mixed

• Date: May 5 - 6, 2026
• Day1: Tue, May 05 8:30 a.m. - 05:30 p.m. ET
• Day2: Wed, May 06 8:30 a.m. - 04:30 p.m. ET
• Location: The Universities at Shady Grove; Building II; 9630 Gudelsky Drive; Rockville, MD 20850; United States

Event Details

The field of generic oral drug products continues to evolve leading to innovative bioequivalence (BE) approaches when conventional in vivo bioequivalence study designs may not be feasible. In response to these evolving complexities, this workshop is designed to address the latest advancements and regulatory challenges in the field, offering a unique platform to engage with all relevant parties, share knowledge, and contribute to the evolution of generic oral product development and regulatory assessment.

Attendees will gain valuable insights into the intricacies of developing generic oral products across diverse areas, including oncology drugs, unavailable reference listed drugs or reference standards, and drug products that are reformulated to mitigate nitrosamine risks. In addition to a series of expert-led presentations and panel discussions, in-person attendees will interact directly with experts from industry, consulting groups, academia and FDA in small group working sessions to deepen their understanding of current practices and challenges, regulatory expectations, and emerging trends. Specifically, the 2-day workshop will cover critical areas such as bioequivalence approaches for oral oncology products, risk assessment and regulatory decision making for nitrosamine-driven reformulation, demonstration of bioequivalence when a reference listed drug or reference standard is unavailable, biopredictive dissolution, and regulatory acceptance of innovative and alternative bioequivalence approaches for generic oral products. These topics reflect the most pressing challenges facing generic oral drug development today and the scientific innovations being deployed to overcome them.

For more information, please visit the Center for Research on Complex Generics website for this Workshop.