ONE Labs Inc., is pleased to have received 'Acceptance' of a second Premarket Tobacco Product Application (PMTA) for ...
With e-cigarette sales booming, the Supreme Court heard arguments over whether the FDA unlawfully blocked approval of more ...
The U.S. Supreme Court examined on Monday the U.S. Food and Drug Administration's refusal to let two e-cigarette companies ...
Supreme Court justices questioned an FDA crackdown that involved rejections on sales of more than a million nicotine products ...
Most Supreme Court justices sounded skeptical of claims Monday that the Food and Drug Administration wrongly moved the ...
Opening arguments in a case centering on the role of flavored vapes see justices ask many questions and display differing ...
The Supreme Court is weighing whether the FDA unlawfully blocked the marketing and sale of sweet flavored nicotine products ...
The justices will hear arguments about the FDA's rejection of some e-cigarettes. High schoolers are at the center of the case ...
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 ...