Otsuka Pharmaceutical Co. v. Price
| Docket Number | 16-5229 |
| Decision Date | 29 August 2017 |
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10 cases
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St. Mary Med. Ctr. v. Becerra
...the administrative record." Otsuka Pharm. Co. v. Burwell , 302 F. Supp. 3d 375, 389 (D.D.C. 2016), aff'd sub nom., Otsuka Pharm. Co. v. Price , 869 F.3d 987 (D.C. Cir. 2017) (cleaned up). In this context, the function of the agency is "to resolve factual issues to arrive at a decision that ......
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Teva Pharm. USA, Inc. v. U.S. Food & Drug Admin.
...in original) (quoting Otsuka Pharm. Co. v. Burwell , 302 F. Supp. 3d. 375, 394 (D.D.C. 2016), aff'd sub nom. Otsuka Pharm. Co. v. Price , 869 F.3d 987 (D.C. Cir. 2017) ). A statutory definition is not required for the meaning of a term to be unambiguous. See Petit , 675 F.3d at 781 (citing ......
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Eagle Pharm., Inc. v. Azar
...drug can be sold or marketed in interstate commerce, the FDA must "certify[ ] the drug’s safety and efficacy." Otsuka Pharm. Co. v. Price , 869 F.3d 987, 989 (D.C. Cir. 2017) (citing 21 U.S.C. § 355(a), (b) ).After a sponsor’s drug has been designated as an orphan drug and approved for mark......
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Amgen Inc. v. Hargan
...whether the agency's [interpretation] is unambiguously foreclosed by the statute." (citation omitted) ); Otsuka Pharm. Co. v. Price , 869 F.3d 987, 995 (D.C. Cir. 2017) (same). If the agency's interpretation "violate[s] Congress's precise instructions or exceed[s] the statute's clear bounda......
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