FDA Releases Additional Regulatory Science Policy Memoranda on PMTA

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May.15.2024

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.

References:

[1] FDA Posts Additional Regulatory Science Policy Memos

Also Read:

[1] John Verbeten Appointed Compliance Office Director by FDA-CTP in 2024

[2] FDA to Host Webinar Celebrating 10th Anniversary of "The Real Cost" Campaign

[3] Consumers and Advocates Welcome FDA-CTP's Health Findings

[4] FDA Issues Warnings to 14 Online Retailers for Unauthorized E-Cigarettes

[5] FDA and DOJ Seize $700k Worth of Illegal E-Cigarettes

[6] FDA Issues MDO on 65 "MNGO Disposable Stick" Vapes of Shenzhen YIBAI Technology

[7] Second Lawsuit Filed Against FDA for Failing to Ban Menthol Cigarettes

#North America #United States #Regulation #FDA #Heated tobacco products

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