drug-approval
2 cases — ← All topics
| Case | Title | Lower Court | Docketed | Status | Flags | Tags | Question Presented |
|---|---|---|---|---|---|---|---|
| 24-1187 | Vanda Pharmaceuticals, Inc. v. Food and Drug Administration, et al. | District of Columbia | 2025-05-21 | Denied | Response RequestedResponse WaivedRelisted (2) | administrative-law agency-discretion drug-approval fda-regulation medical-innovation statutory-interpretation | Whether FDA has acted contrary to its statutory mandate by substituting an evaluation of a drug development program's potential for assessing a new dr… |
| 23A530 | Hope Medical Enterprises, Inc. v. Fagron Compounding Services, LLC, et al. | Ninth Circuit | 2023-12-12 | Presumed Complete | drug-approval enforcement fdca preemption private-litigation state-law | Whether the Food, Drug, and Cosmetic Act's enforcement provision preempts state-law claims that mirror federal drug approval requirements |