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 ...
While the court may still find a flaw in the FDA’s handling of the matter, the three liberal members of the high court as well as Justices Amy Coney Barrett and Brett Kavanaugh, seemingly sided ...
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 ...
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