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PMTAs are required for any new tobacco product seeking FDA marketing order. Learn about the final PMTA rule, how to prepare and submit a PMTA, and the review process and decisions.
Companies may receive marketing authorization through one of the three pathways; the following products have been issued marketing granted orders (MGO) under the PMTA pathway.
Learn how PMI's IQOS Tobacco Heating System was authorized by the U.S. FDA through the PMTA pathway, based on a science-based review of its risks and benefits. Find out what PMTA is and how it applies to new tobacco products in the U.S.
May 24, 2021 · Miami, FLA, May 24, 2021 (GLOBE NEWSWIRE) -- Over 8 months after the September 9 th 2020 PMTA submission deadline, the FDA has finally released the long-awaited and much anticipated list of...
PMTA is a pathway for ENDS products to be approved by FDA based on their public health impact. Learn about the PMTA modules, requirements, and timeline for submitting an application.
A premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product can be legally marketed in the United States.
With so much at stake, understanding what it takes to file a successful PMTA submission is a must during the product development stage so that study designs, planning, and analyses can be part of that process. Here are a few expert tips to help you prepare a successful U.S. FDA PMTA.
