Sarah Marking, MS

More about Sarah

In the nicotine consumer products space, Sarah works closely with clients to plan and submit premarket tobacco product applications (PMTAs) and modified risk tobacco product applications (MRTPAs) across various nicotine product categories, including novel, emerging delivery systems. She combines her extensive industry experience, scientific expertise, and business acumen to navigate the rapidly evolving regulatory landscape and provide practical solutions to regulatory challenges. Sarah supports regulatory strategy across all scientific areas including product design and development, manufacturing, and nonclinical and clinical study programs.  She also supports preparation for Tobacco Products Scientific Advisory Committee (TPSAC) meetings. 

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Sarah supports clients in implementing rigorous quality management systems and production processes to ensure effective manufacturing controls, while establishing compliance with the proposed requirements for tobacco product manufacturing practices (TPMPs).  This work serves as the foundation for a successful regulatory submission on which additional nonclinical and clinical evidence is built.  Sarah also specializes in developing approaches to assess switching behaviors among adult smokers and monitor the prevalence of awareness and use among youth to form the basis of FDA’s determination of whether a product is APPH for the population on the whole.   

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She specializes in helping clients create and navigate multi-product regulatory strategies and product line extensions. These strategies leverage existing scientific evidence through use of supplemental PMTAs (sPMTAs) and tobacco product master files (TPMFs) to minimize regulatory costs and timelines.  In addition to leading submissions to FDA’s Center for Tobacco Products (CTP), Sarah works with clients to explore product submissions through both the NDA and ANDA pathways as the regulatory landscape continues to evolve.