Tobacco

FDA Posts Additional Regulatory Science Policy Memos

5 documents focus on internal roles, responsibilities and processes related to premarket tobacco product application review
FDA
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The Food and Drug Administration (FDA) on Tuesday posted additional regulatory science policy memos focused on internal roles, responsibilities and processes related to premarket tobacco product application (PMTA) review. The release of the memos is part of the FDA's Center for Tobacco Products (CTP) plan following recommendations from the Reagan-Udall Foundation.

Developed between 2020 and 2022, one of the memos also discusses the FDA’s approach to acceptance and filing review at the time it was developed, including discussion of the prioritization of certain applications received for nontobacco nicotine products as of Nov. 4, 2021, the agency said.

The memos provide a snapshot of the center’s internal thinking on a specific topic at a certain point in time, and is subject to change based on the regulatory framework or regulatory science or changes in policy, the FDA said.

The five memos released are:

  • August 3, 2020: Guidelines for Office of Health Communication and Education Consult for Marketing Plan Review and Evaluation
  • March 04, 2021: Clarification of PMTA Review Responsibilities Regarding Harmful and Potentially Harmful Constituent (HPHC) Aerosol and Smoke Yields and Clinical Biomarkers of Exposure (BOE) Data Among Division of Individual Health Science (DIHS), Division of Product Science (DPS) and Division of Nonclinical Science (DNCS)
  • March 30, 2022: Clarification of PMTA Review Responsibilities Between Division of Population Health Science and Division of Individual Health Science
  • May 2, 2022: Addendum to Guidelines for Office of Health Communication and Education Consult for PMTA Marketing Information Review and Evaluation
  • June 01, 2022: Process for implementing new acceptance and filing reviews for PMTAs based on new requirements under 21 CFR 1114

The agency previously said it would be done reviewing applications by the end of last year, but due to challenges in court and amendments made by manufacturers the date has been pushed back to June 30.

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