21 CFR 316.20 - Content and format of a request for orphan-drug designation
| Cite as | 21 CFR 316.20 |
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11 practice notes
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Eagle Pharm., Inc. v. Azar, No. 18-5207
...same rare disease or condition if it can present a plausible hypothesis that its drug may be clinically superior to the first drug." 21 C.F.R. 316.20(a) (emphasis added). Later, after the drug has been approved for marketing, the FDA requires the manufacturer to "demonstrate ... that the dr......
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Depomed, Inc. v. U.S. Dep't of Health & Human Servs., Civil Action No. 12–cv–1592 KBJ
...Congress authorized the FDA to promulgate regulations governing the section 360bb designation process, which the agency has done, see 21 C.F.R. §§ 316.20 –316.30, and those regulations require, among other things, an analysis of the potential clinical superiority of a drug that is being con......
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Braeburn Inc. v. U.S. Food & Drug Admin., Civil Action No. 19-982 (BAH)
...drug as an already approved drug" to "present a plausible hypothesis that its drug may be clinically superior to the first drug." 21 C.F.R. § 316.20(a). Orphan-designated drugs receive 7-year exclusivity periods under the conditions set forth in 21 U.S.C. § 360cc. Before Congress passed FDA......
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Eagle Pharms., Inc. v. Alex M. Azar II in His Official Capacity, Civil Action No. 16-790 (TJK)
...The FDA has thus taken steps to avoid successive grants of orphan-drug exclusivity for the "same drug" to treat the same disease. See 21 C.F.R. §§ 316.20(b)(5), 316.25(a)(3), 316.34(c). The FDA does so at two stages of the process: first when determining whether to designate a drug as an or......
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4 cases
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Eagle Pharm., Inc. v. Azar, No. 18-5207
...rare disease or condition if it can present a plausible hypothesis that its drug may be clinically superior to the first drug." 21 C.F.R. 316.20(a) (emphasis added). Later, after the drug has been approved for marketing, the FDA requires the manufacturer to "demonstrate ... that t......
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Depomed, Inc. v. U.S. Dep't of Health & Human Servs., Civil Action No. 12–cv–1592 KBJ
...Congress authorized the FDA to promulgate regulations governing the section 360bb designation process, which the agency has done, see 21 C.F.R. §§ 316.20 –316.30, and those regulations require, among other things, an analysis of the potential clinical superiority of a drug that is being con......
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Braeburn Inc. v. U.S. Food & Drug Admin., Civil Action No. 19-982 (BAH)
...already approved drug" to "present a plausible hypothesis that its drug may be clinically superior to the first drug." 21 C.F.R. § 316.20(a). Orphan-designated drugs receive 7-year exclusivity periods under the conditions set forth in 21 U.S.C. § 360cc. Before Congress passed......
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Eagle Pharms., Inc. v. Alex M. Azar II in His Official Capacity, Civil Action No. 16-790 (TJK)
...thus taken steps to avoid successive grants of orphan-drug exclusivity for the "same drug" to treat the same disease. See 21 C.F.R. §§ 316.20(b)(5), 316.25(a)(3), 316.34(c). The FDA does so at two stages of the process: first when determining whether to designate a drug as an orph......
2 firm's commentaries
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FDA Nonacquiescence Strategy Fails In Evergreening Case
...status simply by “present[ing] a plausible hypothesis that its drug may be clinically superior to the first drug.” Id. at 327 (quoting 21 C.F.R. 316.20(a)) (emphasis original with the court). Later on, after the FDA acts, a person holding an approved application must “demonstrate . . . that......
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FDA Nonacquiescence Strategy Fails In Evergreening Case
...status simply by "present[ing] a plausible hypothesis that its drug may be clinically superior to the first drug." Id. at 327 (quoting 21 C.F.R. 316.20(a)) (emphasis original with the court). Later on, after the FDA acts, a person holding an approved application must "demonstrate . . . that......