Eagle Pharmaceuticals, Inc. v. Azar
| Docket Number | 18-5207 |
| Decision Date | 13 March 2020 |
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39 cases
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United States v. Thorne
...Rules of Criminal Procedure). Thus, in interpreting any of the Rules, courts must " ‘begin with the text.’ " Eagle Pharms., Inc. v. Azar , 952 F.3d 323, 330 (D.C. Cir. 2020) (quoting City of Clarksville v. FERC , 888 F.3d 477, 482 (D.C. Cir. 2018) ). In conducting its textual analysis, a re......
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Filazapovich v. Dep't of State
...the words of a statute are unambiguous ... judicial inquiry is complete.’ " (alterations in original) (quoting Eagle Pharms., Inc. v. Azar , 952 F.3d 323, 340 (D.C. Cir. 2020) )).2. Unreasonable Delay and Unlawful Withholding Plaintiffs next argue that Defendants have unreasonably delayed a......
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Teva Pharm. USA, Inc. v. U.S. Food & Drug Admin.
...purpose, and legislative history to determine if the Congress has expressed its intent unambiguously.’ " Eagle Pharms., Inc. v. Azar , 952 F.3d 323, 330 (D.C. Cir. 2020) (alteration in original) (quoting U.S. Sugar Corp. v. EPA , 830 F.3d 579, 605 (D.C. Cir. 2016) (per curiam)). If the stat......
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Nasdaq Stock Mkt. LLC v. Sec. & Exch. Comm'n
...At step one, we ask "whether the agency-administered statute is ambiguous on the precise question at issue." Eagle Pharms., Inc. v. Azar , 952 F.3d 323, 330 (D.C. Cir. 2020) (internal quotation marks omitted) (quoting Guedes v. Bureau of Alcohol, Tobacco, Firearms & Explosives , 920 F.3d 1,......
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3 firm's commentaries
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Orphan Drug Exclusivity (ODE) ' FDA Continues Its Attack
...has acted without statutory authority. See Catalyst Pharms., Inc. v. Becerra, 14 F.4th 1299 (11th Cir. 2021); Eagle Pharms., Inc. v. Azar, 952 F.3d 323 (D.C. Cir. 2020) ("Eagle II"); United Therapeutics Corp. v. HHS, No. 17-01577 (ESH), 2020 WL 6498619 (D.D.C. Sept. 2, 2020); Eagle Pharms.,......
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Orphan Drug Act Reform: Will the Loophole be Closed During the Biden Administration?
...(amending 21 U.S.C. § 360cc). 20 See, e.g., Eagle Pharms., Inc. v. Azar, No. 16-790 (TJK), 2018 WL 3838265 (D.D.C. June 8, 2018), aff’d, 952 F.3d 323, reh’g en banc denied 21 H.R. 4712, 116th Cong. (2020). 22 Id. 23 Id. 24 Press Release, Rep. Madeleine Dean, Rep. Dean Elected as Regional Wh......
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FDA Doubles Down On Its Pre-Catalyst Stance On Orphan Drug Exclusivity
...No. 1:19-cv-22425-BB, 9 (11th Cir. 2021); see also 21 USC § 355(b). Id. Id; see also 21 USC § 355(b). See e.g., Eagle Pharm. v. Azar, 952 F.3d 323 (DC Cir. 2020). While the Eagle case was pending, amended the Orphan Drug Act to allow the FDA to impose a clinical superiority requirement when......
1 books & journal articles
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CATALYST PHARMS., INC. V. BECERRA: WHEN THE FOOD AND DRUG ADMINISTRATION REPEATEDLY IGNORES THE PLAIN LANGUAGE OF THE ORPHAN DRUG ACT (ODA).
...replete with reference to the fundamental need to provide treatment for presently untreated patients."). (44) Eagle Pharms., Inc. v. Azar, 952 F.3d 323, 325 (D.C. Cir. (45) 21 U.S.C. [section] 360cc(a). (46) See infra Part II.B. (47) Id. (48) Eagle Pharms., Inc, 952 F.3d at 342 (Williams, J......