Back to: FDA Generic Drugs Forum 2025
Presenter
Reynolds (Rey) Cantave, PharmD
Senior Regulatory Health Project Manager
Enterprise Project Management Staff Office of Quality Assurance (OQA)Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Rey Cantave, PharmD has served as a Project Manager enabling the Office of Pharmaceutical Quality’s response to the Nitrosamine incident since November 2018. He facilitated Subject Matter Expert engagement in the development of Nitrosamine Guidance and serves as are resource to assessment teams on emerging nitrosamine-related issues, enabling the use and communication of best practices.
Abstract
At the 2025 Generic Drugs Forum, Dr. Rey Cantave from FDA’s Office of Pharmaceutical Quality presents an in-depth update on nitrosamine guidance, focusing on evolving strategies for controlling these genotoxic impurities in pharmaceuticals. He distinguishes between small molecule nitrosamines and nitrosamine drug substance-related impurities (NDSRIs), and outlines the Carcinogenic Potency Categorization Approach (CPCA), introduced in 2023, as a predictive model to set acceptable intake limits. Dr. Cantave reviews FDA’s three-step mitigation strategy—risk assessment, confirmatory testing, and reporting changes—and highlights major updates to the 2024 guidance, including broadened scope, revised control thresholds, and reformulation recommendations. Emphasizing collaboration with industry and the importance of continued vigilance, he encourages manufacturers to utilize FDA resources, maintain quality control, and stay responsive to emerging risks.