In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA)...more
FDA’s approach to a premarket tobacco product application (PMTA) raises new questions about whether its marketing denial order was arbitrary and capricious and whether the deliberative-process exemption justifies its...more