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 ...
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 ...
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 ...
But after a long delay, the FDA announced a ban on Juul's products ... Instead, their product got a new generation hooked on nicotine. By 2018, over 3 million high schoolers were vaping, and ...