Save the Dates for 2026 FDA/CRCG Workshops on Complex Generic Product Topics

https://www.complexgenerics.org/?utm_medium=email&utm_source=govdelivery The Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) are excited to announce the upcoming co-hosted workshops planned for 2026. These hybrid events are intended to stimulate scientific dialogue, disseminate current insights about complex generics, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines. Please mark your calendars and plan to join us for the following workshops in 2026: Bioequivalence Innovations for Oral Generic Products: Biowaivers, Bridging, and Generic Development for Oncology and Discontinued Products May 5th-6th, 2026 This 2-day workshop will highlight innovative bioequivalence (BE) approaches for oral generic drug products when conventional in vivo BE studies may not be feasible, with an emphasis on oncology products and biopharmaceutics classification system (BCS) Class IV drugs. The workshop will explore biowaiver pathways supported by bio-predictive dissolution, absorption modeling, and model-integrated evidence. The program will also address strategies for bridging BE when designated reference standards are unavailable for discontinued products, when surrogate comparators are needed, and when nitrosamine-impacted drug products are reformulated. Sessions will highlight adaptive PK study designs, scientifically justified bridging approaches, and the regulatory considerations for implementing these alternative BE strategies. Data integrity, reproducibility, model credibility, and well-defined criteria will be emphasized for establishing BE in complex and challenging oral generic drug development scenarios. Navigating the GLP-1 Generic Pathway: From Peptide to Patient September 23rd-24th, 2026 This 2-day workshop will address some of the key product development and regulatory assessment considerations for generic GLP-1 agonist products. The goal of this workshop is to bring clarity and promote discussions over evidence-based approaches to establish the acceptable critical quality attributes of recombinant and synthetic peptide products, address manufacturing quality considerations, and tackle the unique challenges associated with drug-device combination products, when applicable. Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods October 14th-15th, 2026 The transition of BE recommendations for locally-acting inhalation and nasal products to option-based frameworks has opened new opportunities by incorporating innovative in vitro, in vivo, and in silico methods as alternatives to comparative clinical endpoint BE studies. These advanced methodologies offer promising pathways for more efficient generic product development, though they require thoughtful implementation to maximize their potential. This workshop will harness collective expertise to identify best practices and develop strategic approaches that optimize study design, eliminate redundancies, and enhance evaluation efficiency—ultimately supporting first cycle approvals while addressing unique considerations for products with compositional differences. Long-Acting Injectable (LAI) Generics: Navigating Technical Hurdles in Product Development and Regulatory Assessment December 1st-2nd, 2026 The purpose of this 2-day workshop is to facilitate an in-depth look at current challenges relating to LAI product characterization, drug release mechanisms, in vivo BE study conduct, and factors that impact product development and regulatory assessment. The workshop will discuss current thinking on LAI drug release mechanisms, in vitro methodologies, and predictive modeling approaches to support LAI generic drug development and regulatory assessment. Sessions will discuss common deficiencies observed during ANDA assessment, alternative BE study designs, and model-integrated evidence approaches that enable a more efficient and feasible BE assessment. The workshop will also facilitate a discussion about permissible formulation differences and their impact on product performance, reverse engineering approaches, and novel excipient evaluation strategies.