21 CFR 514.1 - Applications
| Cite as | 21 CFR 514.1 |
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92 practice notes
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Stauber v. Shalala, No. 94-C-0090-C.
...or drug sponsor to show that the new animal drug is both effective and safe under the proposed conditions of use. 21 U.S.C. § 360b; 21 C.F.R. § 514.1(b)(8). Effectiveness must be demonstrated on the basis of "substantial evidence" that the drug "will have the effect it purports or is repres......
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Inst. for Fisheries Res. v. Hahn, Case No. 16-cv-01574-VC
...To that end, the document canvasses the existing statutory and regulatory requirements for new animal drugs. See 21 U.S.C. § 360b ; 21 C.F.R. § 514.1. In the document, the FDA acknowledged that the "application of some of the statutory and regulatory requirements for new animal drug applica......
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US v. An Article of Drug Neo-Terramycin, Civ. A. No. CA3-79-615-D.
...effectiveness. X-Otag Plus Tablets, 441 F.Supp. at 111. This requirement is implicit in the FDA's combination policy, codified at 21 CFR § 514.1(b)(8)(v): 540 F. Supp. 377 Each ingredient designated as active in any new animal drug combination must make a contribution to the effect in the m......
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Natural Res. Def. Council, Inc. v. U.S. Food & Drug Admin., No. 11 Civ. 3562(THK).
...[872 F.Supp.2d 322]unless the agency finds that the drug use has not been shown to be safe or effective. See21 U.S.C. § 360b(d)(1); 21 C.F.R. § 514.1(b)(8)(i). Once the FDA has approved the use of a new animal drug, the applicant holder must make periodic reports to the Agency describing ex......
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15 cases
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Inst. for Fisheries Res. v. Hahn, Case No. 16-cv-01574-VC
...To that end, the document canvasses the existing statutory and regulatory requirements for new animal drugs. See 21 U.S.C. § 360b ; 21 C.F.R. § 514.1. In the document, the FDA acknowledged that the "application of some of the statutory and regulatory requirements for new animal drug applica......
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US v. An Article of Drug Neo-Terramycin, Civ. A. No. CA3-79-615-D.
...effectiveness. X-Otag Plus Tablets, 441 F.Supp. at 111. This requirement is implicit in the FDA's combination policy, codified at 21 CFR § 514.1(b)(8)(v): 540 F. Supp. 377 Each ingredient designated as active in any new animal drug combination must make a contribution to the effect in the m......
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Stauber v. Shalala, No. 94-C-0090-C.
...or drug sponsor to show that the new animal drug is both effective and safe under the proposed conditions of use. 21 U.S.C. § 360b; 21 C.F.R. § 514.1(b)(8). Effectiveness must be demonstrated on the basis of "substantial evidence" that the drug "will have the effect it purports or is repres......
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Natural Res. Def. Council, Inc. v. U.S. Food & Drug Admin., No. 11 Civ. 3562(THK).
...[872 F.Supp.2d 322]unless the agency finds that the drug use has not been shown to be safe or effective. See21 U.S.C. § 360b(d)(1); 21 C.F.R. § 514.1(b)(8)(i). Once the FDA has approved the use of a new animal drug, the applicant holder must make periodic reports to the Agency describing ex......
Request a trial to view additional results