ONE Labs Inc., is pleased to have received 'Acceptance' of a second Premarket Tobacco Product Application (PMTA) for ...
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 ...
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 ...