The U.S. Food and Drug Administration (FDA) has announced its research priorities for fiscal year 2026, setting the stage for advances in generic drug development and authorization. Released on September 30, the priorities were developed as part of the Generic Drug User Fee Amendments (GDUFA III) agreement and reflect FDA’s focus on addressing complex challenges while expanding patient access to affordable therapies.
Generic drugs remain essential for healthcare systems worldwide, but evolving formulations, delivery systems, and safety concerns require increasingly sophisticated approaches to regulation. FDA’s updated priorities aim to strengthen scientific understanding, modernize review processes, and make the development of generics more efficient.
One of the agency’s central goals is tackling nitrosamine drug substance-related impurities (NDSRIs), a class of potentially harmful compounds that have prompted recalls and heightened regulatory scrutiny in recent years. FDA’s research will focus on understanding how these impurities form, assessing exposure risks, and developing efficient pathways for abbreviated new drug application (ANDA) sponsors to meet compliance expectations.
The agency is also investing in new approaches for demonstrating bioequivalence, particularly for complex active ingredients, advanced dosage forms, and drug-device combination products. Research will address how variations in design—such as differences in software, hardware, or delivery mechanisms—may influence therapeutic equivalence or increase risks of medication errors. These efforts will be key in ensuring both patient safety and the reliability of generic alternatives.
Another area of emphasis is the integration of advanced modeling and simulation. FDA is exploring frameworks that combine in silico models with in vivo and in vitro data to reduce trial failure risks and support virtual bioequivalence studies. If successful, this could significantly cut development time and costs for sponsors. By incorporating predictive analytics, FDA hopes to provide clearer expectations for industry and minimize uncertainties that often delay approvals.
FDA is also prioritizing research into artificial intelligence (AI) and machine learning (ML) as tools for regulatory decision-making. By leveraging these technologies, the agency aims to increase consistency in its evaluations, detect risks earlier, and streamline scientific reviews. The potential use of AI-driven models could not only improve efficiency but also enhance transparency, offering stakeholders more confidence in the approval process.
For generic manufacturers, these priorities highlight the importance of investing in proactive compliance strategies. With FDA signaling closer scrutiny of impurities, bioequivalence, and device-drug interfaces, sponsors must prepare to demonstrate rigorous scientific evidence at every stage. Companies that build strong data science capabilities and integrate advanced modeling into their development programs will be better equipped to meet FDA’s expectations.
At EMMA International, we help organizations stay ahead of regulatory shifts like these. Our expertise spans nitrosamine risk assessment, bioequivalence study design, AI-enabled regulatory strategies, and submission support. By combining regulatory insight with scientific rigor, we ensure that our clients can navigate FDA’s priorities with confidence while advancing therapies that patients rely on.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference
Al-Faruque, F. (2025, October 1). FDA lists its upcoming research priorities for generic drugs. Regulatory Affairs Professionals Society.
