| 23-1187 |
Food and Drug Administration, et al. v. R.J. Reynolds Vapor Co., et al. |
Fifth Circuit |
2024-05-02 |
Judgment Issued |
Amici (9) |
administrative-law circuit-court civil-procedure fda fda-authorization federal-courts judicial-review product-distribution standing statutory-interpretation tobacco-regulation |
Whether a manufacturer may file a petition for review in a circuit (other than the D.C. Circuit) where it neither resides nor has its principal place … |
| 23-395 |
Alliance for Hippocratic Medicine, et al. v. Food and Drug Administration, et al. |
Fifth Circuit |
2023-10-16 |
Denied |
Amici (3) |
abortion abortion-medication administrative-procedure-act drug-regulation fda fda-approval generic-drugs medical-safety mifepristone subpart-h |
Whether Cross-Petitioners' challenge to FDA's 2000 mifepristone approval is timely |
| 23-235 |
Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine, et al. |
Fifth Circuit |
2023-09-12 |
Judgment Issued |
Amici (3)Relisted (2) |
abortion abortion-medication administrative-law agency-action article-iii-standing civil-procedure fda fda-regulations mifepristone preliminary-relief standing |
Whether respondents have Article III standing to challenge FDA's 2016 and 2021 actions |
| 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 |
Whether FDA's marketing denial order was arbitrary and capricious |
| 21-1342 |
Jacobus Pharmaceutical Company, Inc. v. Catalyst Pharmaceuticals, Inc., et al. |
Eleventh Circuit |
2022-04-11 |
Dismissed |
|
administrative-law circuit-split drug-exclusivity fda fda-regulation lambert-eaton-myasthenic-syndrome orphan-drug-act rare-disease statutory-interpretation |
Does the Orphan Drug Act unambiguously foreclose FDA's interpretation that the scope of orphan-drug exclusivity is tied to a drug's approved use? |