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16 results for “Food and Drug Administration, et al.”

Case Title Lower Court Docketed Status Tags Question Presented
24-1187 Vanda Pharmaceuticals, Inc. v. Food and Drug Administration, et al. District of Columbia 2025-05-21 Denied 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…
24A871 Vanda Pharmaceuticals, Inc. v. Food and Drug Administration, et al. District of Columbia 2025-03-12 Presumed Complete None
24A724 Johnny Copper, LLC v. Food and Drug Administration, et al. Eleventh Circuit 2025-01-23 Presumed Complete administrative-law agency-overreach fda-regulation procedural-due-process regulatory-burden statutory-interpretation Whether the FDA exceeded its statutory authority in issuing a regulatory order that imposes substantial burdens on a regulated entity without providin…
24-189 R.J. Reynolds Tobacco Company, et al. v. Food and Drug Administration, et al. Fifth Circuit 2024-08-21 Denied commercial-speech first-amendment government-mandated-warnings graphic-warnings tobacco-regulation zauderer-standard Whether provocative and misleading government-mandated graphic warnings on cigarette packaging are 'purely factual and uncontroversial' under Zauderer…
23-1187 Food and Drug Administration, et al. v. R.J. Reynolds Vapor Co., et al. Fifth Circuit 2024-05-02 Judgment Issued 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 …
23-1161 Children’s Health Defense, et al. v. Food and Drug Administration, et al. Fifth Circuit 2024-04-26 Denied agency-action article-iii case-or-controversy constitutional-standing injury-in-fact resource-diversion standing vaccine-safety Whether a Constitutionally cognizable case or controversy exists under Article III
23-395 Alliance for Hippocratic Medicine, et al. v. Food and Drug Administration, et al. Fifth Circuit 2023-10-16 Denied 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 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
22A902 Food and Drug Administration, et al. v. Alliance For Hippocratic Medicine, et al. Fifth Circuit 2023-04-14 Presumed Complete None
22-584 Children’s Health Defense, et al. v. Food and Drug Administration, et al. Sixth Circuit 2022-12-23 Denied agency-action article-iii case-or-controversy constitutional-standing injury resource-diversion risk-of-injury standing third-party third-party-injury Whether a Constitutionally cognizable case or controversy exists under Article III
20-1203 Moose Jooce, et al. v. Food and Drug Administration, et al. District of Columbia 2021-03-03 Denied administrative-procedure-act agency agency-law appointments-clause due-process government-action ratification ratification-doctrine rulemaking-authority standing Whether a government official has the power to validate the unauthorized actions of other officials is presumptively determined by the law of agency, …
20-850 Big Time Vapes, Incorporated, et al. v. Food and Drug Administration, et al. Fifth Circuit 2020-12-28 Denied administrative-discretion administrative-law constitutional-limits executive-authority executive-power legislative-authority legislative-delegation non-delegation-doctrine separation-of-powers tobacco-control-act tobacco-product-regulation Whether Petitioners have stated a claim that § 387a(b) grants excessive policymaking discretion to the executive branch to determine which tobacco pro…
20-295 Hi-Tech Pharmaceuticals, Inc., et al. v. Food and Drug Administration, et al. Eleventh Circuit 2020-09-08 Denied botanical-ingredients constituent-definition dietary-supplements dmaa DSHEA FDA-approval federal-food-drug-and-cosmetic-act geranium-plants prior-history-of-use trace-quantities Whether a substance that naturally occurs in a plant is a 'constituent' of an 'herb or other botanical' under the Dietary Supplement Health and Educat…
20A34 Food and Drug Administration, et al. v. American College of Obstetricians and Gynecologists, et al. Fourth Circuit 2020-08-26 Presumed Complete None
23A300 Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine, et al. Fifth Circuit Presumed Complete None Question not identified.
23A712 Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine, et al. Fifth Circuit Presumed Complete administrative-law chemical-abortion drug-safety fda-regulation medical-procedure reproductive-rights Whether the FDA's regulatory framework for chemical abortion drugs satisfies the requirements of the Food, Drug, and Cosmetic Act and does not pose un…