The FDA contends the manufacturers failed to show their products were more likely to help existing smokers switch to vaping than to hook another generation of Americans on nicotine.
Her expectation is that once the FDA completes its review of the premarket tobacco product applications (PMTAs) for the category and determines that an oral nicotine pouch is appropriate for the ...
The End-of-Phase 2 meeting resulted in alignment with the FDA on the proposed Phase 3 study design, including the inclusion/exclusion criteria, primary and secondary efficacy objectives, definition of ...
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