FDA Posts Regulatory Science Policy Memos Related to the Agency’s Review of Premarket Applications
Today, FDA posted additional regulatory science policy memos related to the agency’s review of premarket applications. This release includes thirteen memos developed between 2020 and 2023 that describe the process and prioritization methods used to conduct filing and review of PMTAs for flavored e-cigarettes and other PMTAs, as well as the bases to support specific actions related to environmental assessments.
In April, FDA resumed the posting of regulatory science policy memos. This is now the fourth batch of released memos in 2024, and including those posted today, FDA has released a total of 26 memos. The release of these latest memos reflects the center’s commitment to enhance transparency consistent with the December 2022 evaluation of the center by an independent expert panel facilitated by the Reagan-Udall Foundation. Visit the FDA website to read more about FDA’s actions in response to the evaluation.