The Supreme Court appeared unsympathetic Monday to a challenge from the maker of flavored e-cigarette products to an FDA decision denying authorization to bring them to market.
The Supreme Court will hear a vaping case on Monday, weighing federal regulators’ decisions blocking sweet vaping products after e-cigarette use spiked among kids.
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 ...