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FDA Issues 5 New Policy Memos Focusing on Pre-Market Review Process for Tobacco Products

June 30,2024 | View: 3504

According to a May 14 announcement by the U.S. Food and Drug Administration (FDA), the FDA has released additional regulatory science policy memoranda focusing on internal roles, responsibilities, and processes related to the review of premarket tobacco product applications (PMTAs). There are five memos in this release, each prepared between 2020 and 2022. These memoranda describe internal roles and responsibilities for the review of scientific disciplines and marketing information. One of the memoranda also discusses FDA's approach to intake and filing reviews as they are developed, including the prioritization of certain non-tobacco nicotine product applications received by November 4, 2021.1

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