FDA Releases Additional Regulatory Science Policy Memoranda on PMTA

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FDA Releases Additional Regulatory Science Policy Memoranda on PMTA
FDA announces new regulatory science policy memoranda focusing on premarket tobacco product application (PMTA) review roles, responsibilities, and processes.

According to the US Food and Drug Administration (FDA), on May 14th, the FDA released an additional regulatory science policy memorandum focusing on internal roles, responsibilities, and processes related to the Pre-Market Tobacco Product Application (PMTA) review.


The five memorandums released this time were completed between 2020 and 2022.


These memoranda describe the internal roles and responsibilities for reviewing scientific disciplines and marketing information. One memorandum also discusses the FDA's approach to acceptance and filing reviews in development, including prioritizing certain non-tobacco nicotine product applications received before November 4, 2021.


These 5 memos include:


August 3, 2020: Guidelines for the review and evaluation of marketing plans for the Office of Health Communication and Education March 4, 2021: Clarification on harmful and potentially harmful constituents (HPHC), aerosol and smoke production, and Biomarkers of Exposure (BOE) data in relation to the Premarket Tobacco Product Application (PMTA) review responsibilities of the Division of Individual Health Science (DIHS), Division of Product Science (DPS), and Division of Non-Clinical Science (DNCS) March 30, 2022: Clarification of PMTA review responsibilities between the Division of Population Health Science and Division of Individual Health Science May 2, 2022: Supplementary explanation of guidelines for the review and evaluation of marketing information for PMTA from the Office of Health Communication and Education June 1, 2022: Implementation of new PMTA acceptance and filing review processes in accordance with the new requirements of 21 CFR 1114.


Furthermore, the memorandum to be released should not be used as a tool, guide, or manual for preparing applications or submissions to the FDA. For applicants seeking to sell new tobacco products, the FDA has already issued final regulations, such as the PMTA Final Rule, which describe the required content, format, and review process for PMTAs, as well as guidance documents.


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