21 CFR 316.25 - Refusal to grant orphan-drug designation
| Cite as | 21 CFR 316.25 |
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4 practice notes
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Pharm. Research & Mfrs. of Am. v. U.S. Dep't of Health & Human Servs., Civil Action No.: 14–1685 (RC)
...plausible basis for expecting the drug to be effective in the prevention, diagnosis, or treatment of that disease or condition." 21 C.F.R. § 316.25(a)(2) (emphasis added). Nor does the administrative record appear to support some of the negative consequences that HHS portends. As PhRMA......
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Depomed, Inc. v. U.S. Dep't of Health & Human Servs., Civil Action No. 12–cv–1592 KBJ
...more easily with the FDA's litigation position in this case. See 78 Fed.Reg. 35,117 (Jun. 12, 2013). Specifically, the FDA changed 21 C.F.R. § 316.25 to provide that a clinical superiority hypothesis is required for designation where “the drug is the same drug as an already approved drug,” ......
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Research v. U.S. Dep't of Health & Human Servs., Civil Action No.: 14-1685 (RC)
...plausible basis for expecting the drug to be effective in the prevention, diagnosis, or treatment of that disease or condition." 21 C.F.R. § 316.25(a)(2) (emphasis added). Nor does the administrative record appear to support some of the negative consequences that HHS portends. As PhRMA......
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Eagle Pharms., Inc. v. Alex M. Azar II in His Official Capacity, Civil Action No. 16-790 (TJK)
...drug sponsor must submit "a medically plausible hypothesis for the possible clinical superiority of the subsequent drug." 21 C.F.R. § 316.25(a)(3). At the marketing-approval stage, the FDA requires applicants to go beyond a mere hypothesis and provide evidence of actual clinical s......
4 cases
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Pharm. Research & Mfrs. of Am. v. U.S. Dep't of Health & Human Servs., Civil Action No.: 14–1685 (RC)
...plausible basis for expecting the drug to be effective in the prevention, diagnosis, or treatment of that disease or condition." 21 C.F.R. § 316.25(a)(2) (emphasis added). Nor does the administrative record appear to support some of the negative consequences that HHS portends. As PhRMA......
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Depomed, Inc. v. U.S. Dep't of Health & Human Servs., Civil Action No. 12–cv–1592 KBJ
...more easily with the FDA's litigation position in this case. See 78 Fed.Reg. 35,117 (Jun. 12, 2013). Specifically, the FDA changed 21 C.F.R. § 316.25 to provide that a clinical superiority hypothesis is required for designation where “the drug is the same drug as an already approved drug,” ......
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Research v. U.S. Dep't of Health & Human Servs., Civil Action No.: 14-1685 (RC)
...plausible basis for expecting the drug to be effective in the prevention, diagnosis, or treatment of that disease or condition." 21 C.F.R. § 316.25(a)(2) (emphasis added). Nor does the administrative record appear to support some of the negative consequences that HHS portends. As PhRMA......
-
Eagle Pharms., Inc. v. Alex M. Azar II in His Official Capacity, Civil Action No. 16-790 (TJK)
...drug sponsor must submit "a medically plausible hypothesis for the possible clinical superiority of the subsequent drug." 21 C.F.R. § 316.25(a)(3). At the marketing-approval stage, the FDA requires applicants to go beyond a mere hypothesis and provide evidence of actual clinical s......