The Food and Drug Administration (FDA) has recently released a set of regulatory science policy memos focused on the premarket tobacco product application (PMTA) review process. These memos provide insight into the internal thinking of the FDA’s Center for Tobacco Products (CTP) and their approach to acceptance and filing review, including the prioritization of certain applications for nontobacco nicotine products.
The five memos released cover various aspects of the PMTA review process, including guidelines for marketing plan review, clarification of responsibilities regarding harmful constituents and clinical biomarkers, and processes for implementing new acceptance and filing reviews. These memos were developed between 2020 and 2022 and provide a snapshot of the FDA’s approach at a specific point in time.
Despite initial plans to complete the review of PMTAs by the end of last year, challenges in court and amendments made by manufacturers have pushed back the deadline to June 30. These regulatory science memos are part of the FDA’s ongoing efforts to ensure the safety and effectiveness of tobacco products on the market.
