Back to: FDA Generic Drugs Forum 2025
Presenter
Geoffrey Wu, PhD, PHP, CPH
Commander, United States Public Health Service (USPHS)
Acting Director, Office of Product Quality Assessment I (OPQA I)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Commander Geoffrey Wu joined the FDA’s Office of Testing and Research (OTR) in 2010, has served in multiple capacities, including research scientist, science staff, chemistry reviewer, staff supervisor, Associate Director of Sciences and Communication (ADSC), acting Division Director, acting Office Director, and Deputy Office Director. He is a scientist officer in the United States Public Health Service. Throughout his FDA tenure, he has been deeply involved, leading or co-leading regulatory review and research for PDUFA and GDUFA programs. Between 2013 and 2017, he served as a founding member on the OPQ Emerging Technology Team (ETT). In the recent years, he has been a core and/or leading member in multiple policy and/or scientific development efforts, such as emerging technology, continuous manufacturing, comparability protocols, knowledge-aided assessment and standard submissions (KASA), pharmaceutical quality chemistry manufacturing and controls (PQ/CMC, aka Structured Pharmaceutical Quality Submissions (SPQA)), novel complex generic drugs, and advanced analytics. He has training and education in pharmacy, pharmaceutical science, protein chemistry, polymer chemistry, process analytical technology, and data science.
Abstract
In his keynote at the 2025 Generic Drugs Forum, Geoffrey Wu of the FDA’s Office of Pharmaceutical Quality (OPQ) highlights OPQ’s 10-year milestone and its ongoing role in ensuring drug quality across new drugs, generics, biologics, and OTCs. He emphasizes the use of integrated quality assessments and the KASA system, now applied to half of ANDA reviews, as tools to enhance consistency and efficiency. Wu outlines OPQ’s recent reorganization to better align with drug programs and support a lifecycle approach to quality oversight. He also showcases the Emerging Technology Program, which fosters innovation in areas like continuous manufacturing and 3D printing. In 2024, OPQ contributes to over 1,000 drug approvals and plays a key role in global regulatory initiatives. Wu closes by stressing the importance of collaboration between the FDA, industry, and partners to uphold product quality across a drug’s entire lifecycle.