marketing-authorization

2 cases — ← All topics

Case Title Lower Court Docketed Status Flags Tags Question Presented
23-799 Magellan Technology, Inc. v. Food and Drug Administration Second Circuit 2024-01-24 Denied Amici (1)Relisted (4) administrative-procedure-act agency-rulemaking arbitrary-and-capricious circuit-split comparative-efficacy electronic-nicotine-delivery-systems ends-products fda-regulation marketing-authorization reliance-interests youth-access Whether FDA's denial of Petitioner's marketing applications for flavored ENDS was arbitrary and capricious where FDA based the denial solely on a prev…
22-1112 Avail Vapor, LLC, et al. v. Food and Drug Administration Fourth Circuit 2023-05-15 Denied Amici (3)Relisted (2) administrative-law administrative-procedure-act arbitrary-and-capricious evidence-standard evidentiary-standard fda fda-regulation marketing-authorization premarket-applications tobacco-product-regulation tobacco-products In 2016, FDA extended its jurisdiction over "tobacco products" under the Federal Food, Drug, and Cosmetic Act to electronic nicotine delivery system…