21 C.F.R. §514.111 - Refusal to approve an application
| Cite as | 21 C.F.R. §514.111 |
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7 practice notes
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Human drugs, biological products, and animal drugs; foreign and domestic establishment registration and listing requirements,
...establishment that is not registered. For consistency with current Sec. 314.125(b)(11), we are proposing to revise Sec. 514.111(a)(12) (21 CFR 514.111(a)(12)) for NADAs to state that we will refuse to approve an application if ``the drug will be manufactured in whole or in part in an establ......
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Part II
...establishment that is not registered. For consistency with current Sec. 314.125(b)(11), we are proposing to revise Sec. 514.111(a)(12) (21 CFR 514.111(a)(12)) for NADAs to state that we will refuse to approve an application if ``the drug will be manufactured in whole or in part in an establ......
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Stauber v. Shalala, No. 94-C-0090-C.
...4) whether it is likely that the conditions of use proposed or suggested in the labeling will be followed. 21 U.S.C. § 360b(d)(2); 21 C.F.R. § 514.111(a)(4). The FDA is required to take into account the drug's effect on the health of the target animal. 21 U.S.C. § 321(u). A new drug applica......
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U.S. v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, Etc., 82-1381
...studies. For example, the regulation requires certain standards for "[t]he method of selection of the animals to be studied ...." 21 C.F.R. Sec. 514.111(a)(5)(ii) (1983) (emphasis added). Since Pfizer has wholly failed to provide any adequate and well-controlled studies that compare the eff......
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5 cases
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Stauber v. Shalala, 94-C-0090-C.
...and 4) whether it is likely that the conditions of use proposed or suggested in the labeling will be followed. 21 U.S.C. § 360b(d)(2); 21 C.F.R. § 514.111(a)(4). The FDA is required to take into account the drug's effect on the health of the target animal. 21 U.S.C. § 321(u). A new drug app......
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U.S. v. An Article of Drug Consisting of 4,680 Pails, More or Less, Each Pail Containing 60 Packets, Etc., 82-1381
...studies. For example, the regulation requires certain standards for "[t]he method of selection of the animals to be studied ...." 21 C.F.R. Sec. 514.111(a)(5)(ii) (1983) (emphasis added). Since Pfizer has wholly failed to provide any adequate and well-controlled studies that compare the eff......
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American Cyanamid Co. v. Food and Drug Administration, 77-1969
...the raw data are available in the application.Cyanamid submitted such tests. See notes 57-158 Infra and accompanying text. See also 21 C.F.R. § 514.111 (1978) (essentially reiterating the demands of § 512(d), quoted in text at note 14 Supra, with respect to safety tests). Nor do counsel for......
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Masti-Kure Products Co., Inc. v. Califano, MASTI-KURE
...of the methods of analysis and an evaluation of data derived from the study, including any appropriate statistical methods." Compare 21 C.F.R. § 514.111(a)(5)(iv) (1977), Supra note 2. The Court stated that "(a) mere reading of the study submitted will indicate whether the study is totally ......
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1 provisions
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PL 104-250, HR 2508 – To amend the Federal Food, Drug, and Cosmetic Act to provide for improvements in the process of approving and using animal drugs, and for other purposes.
...dated October 21, 1991. Until the regulations required by subparagraph (A) are issued, nothing in the regulations published at 21 C.F.R. 514.111(a)(5) (April 1, 1996) shall be construed to compel the Secretary of Health and Human Services to require a field investigation under section 5......