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 ...
ONE Labs Inc., is pleased to have received 'Acceptance' of a second Premarket Tobacco Product Application (PMTA) for ...
In an interview with Reuters, the FDA’s commissioner, Scott Gottlieb said the agency is “re-evaluating and modernising” its approach to nicotine replacement therapies (NRT), typically sold ...
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.
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 ...