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.
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 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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