US FDA nitrosamine specific initiatives in its Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives for Fiscal Year (FY) 2022, among others include: (a) assess the risk of human exposure to harmful impurities (b) Expand the scientific understanding of the role of excipients in generic drug products, related to the formation or mitigation of harmful impurities such as nitrosamines (c) develop methods and integrated technological solutions that will allow FDA to leverage AI tools and large data sets (such as the development of models and data to support quantitative structure-activity relationship (QSAR)-based methods for harmful impurities such as nitrosamines) to support regulatory decisions and to improve post-market surveillance of generic drug substitution.
Will read across and QSAR be the leading tool in assessment of nitrosamine ?