FDA/CRCG Workshop to Address Bioequivalence Innovations for Generic Oral Products

The U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) are co-hosting a workshop focused on innovations in bioequivalence (BE) for generic oral drug products. Scheduled for May 5, 2026, the event will delve into advanced BE approaches that are becoming increasingly relevant as the field of generic pharmaceuticals continues to evolve. These innovative methods are particularly crucial in scenarios where traditional in vivo bioequivalence study designs may not be practical or feasible.

The workshop's agenda is set to cover several key areas, including biowaivers, which allow for the approval of generic drugs without conducting in vivo BE studies under specific conditions, and bridging studies, which are used to extrapolate BE data from one formulation or population to another. A significant focus will also be placed on the development of generic oncology products, an area that often presents unique challenges due to the complexity of the drugs and the patient populations.

Furthermore, the workshop will address the development of generic versions of discontinued products. This aspect is important for ensuring continued patient access to essential medicines, even when the original brand-name product is no longer on the market. By exploring these topics, the FDA and CRCG aim to foster discussions and share knowledge that can facilitate the development and approval of complex generic oral products, ultimately benefiting public health by increasing access to affordable medications.