In his 2001 book, A Question of Intent, former Food and Drug Administration (FDA) Commissioner David Kessler highlighted research long suppressed by Big Tobacco that showed how reduced-nicotine ...
arises out of a 2009 law giving the FDA authority to regulate tobacco and other nicotine products. Because it took a long time for the FDA to start enforcing this law against vapes, many ...
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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